Dapagliflozin History and Updates

250 events · 2002 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

477
FDA Approvals
91
Label Revisions
2,286
Trial Milestones
8
Pivotal Publications
Dapagliflozin — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028202920302031Trial: NCT07539259 2026-12-31 → 2029-08-31 (primary completion)Trial: NCT07342764 2026-09-30 → 2028-11-30 (primary completion)Trial: NCT07516847 2026-09-30 → 2029-01-31 (primary completion)Trial: NCT07624305 2026-09-01 → 2030-07-01 (primary completion)Trial: NCT07595289 2026-08-01 → 2026-12-31 (primary completion)Trial: NCT07056699 2026-07-15 → 2027-06-01 (primary completion)Trial: NCT07396844 2026-07-01 → 2026-07-31 (primary completion)Trial: NCT07310433 2026-06-01 → 2029-10-30 (primary completion)Trial: NCT07323524 2026-06-01 → 2029-07-31 (primary completion)Trial: NCT07482943 2026-04-30 → 2028-04-30 (primary completion)Trial: NCT07392788 2026-04-30 → 2027-12-31 (primary completion)Trial: NCT07405216 2026-04-23 → 2027-05-30 (primary completion)Trial: NCT07547878 2026-04-09 → 2029-03-31 (primary completion)Trial: NCT06907251 2026-04-01 → 2028-06-30 (primary completion)Trial: NCT07491042 2026-04-01 → 2026-09-30 (primary completion)Trial: NCT07469722 2026-03-23 → 2028-01-31 (primary completion)Trial: NCT07273838 2026-03-05 → 2028-08-31 (primary completion)Trial: NCT07291297 2026-03-04 → 2028-10-31 (primary completion)Trial: NCT07403955 2026-02-28 → 2027-12-31 (primary completion)Trial: NCT07387900 2026-02-28 → 2027-09-30 (primary completion)Trial: NCT07351643 2026-02-25 → 2026-10-30 (primary completion)Trial: NCT07404137 2026-02-16 → 2026-04-02 (primary completion)Trial: NCT07368569 2026-02-06 → 2026-03-14 (primary completion)Trial: NCT07372625 2026-02-04 → 2027-03-31 (primary completion)Trial: NCT07436663 2026-02-01 → 2027-11-01 (primary completion)Trial: NCT06072326 2026-01-31 → 2027-12-31 (primary completion)Trial: NCT07351864 2026-01-18 → 2026-04-30 (primary completion)Trial: NCT07399470 2026-01-09 → 2026-02-28 (primary completion)Trial: NCT07331727 2026-01-01 → 2026-09-30 (primary completion)Trial: NCT07295223 2025-12-30 → 2026-08-31 (primary completion)Trial: NCT07297589 2025-12-30 → 2027-01-31 (primary completion)Trial: NCT07311551 2025-12-24 → 2026-12-31 (primary completion)Trial: NCT07280585 2025-12-16 → 2030-05-15 (primary completion)Trial: NCT07222917 2025-12-05 → 2027-05-24 (primary completion)Trial: NCT07025629 2025-12-02 → 2029-01-15 (primary completion)Trial: NCT07174687 2025-12-02 → 2027-12-31 (primary completion)Trial: NCT07235280 2025-12-02 → 2028-06-29 (primary completion)Trial: NCT06954090 2025-11-20 → 2026-11-30 (primary completion)Trial: NCT07214818 2025-11-15 → 2026-07-05 (primary completion)Trial: NCT07239011 2025-11-01 → 2026-11-20 (primary completion)Trial: NCT06707012 2025-10-01 → 2026-06-30 (primary completion)Trial: NCT07108985 2025-09-30 → 2029-09-01 (primary completion)Trial: NCT07333742 2025-09-29 → 2025-11-27 (primary completion)Trial: NCT07372118 2025-09-27 → 2025-12-29 (primary completion)Trial: NCT06922656 2025-09-15 → 2026-09-01 (primary completion)Trial: NCT07076615 2025-08-31 → 2026-05-31 (primary completion)Trial: NCT06750458 2025-08-20 → 2026-10-20 (primary completion)Trial: NCT07204743 2025-08-15 → 2026-06-30 (primary completion)Trial: NCT07491718 2025-08-08 → 2028-08-09 (primary completion)Trial: NCT07266766 2025-08-05 → 2025-09-24 (primary completion)Trial: NCT05607316 2025-07-31 → 2028-06-30 (primary completion)Trial: NCT07120828 2025-07-15 → 2025-08-30 (primary completion)Trial: NCT07082114 2025-07-14 → 2027-02-16 (primary completion)Trial: NCT07254572 2025-07-10 → 2029-08-01 (primary completion)Trial: NCT07083401 2025-07-05 → 2026-07-05 (primary completion)Trial: NCT07083388 2025-07-03 → 2026-07-03 (primary completion)Trial: NCT07239570 2025-06-20 → 2028-06-30 (primary completion)Trial: NCT07026968 2025-06-20 → 2026-10-30 (primary completion)Trial: NCT07033585 2025-06-15 → 2026-10-18 (primary completion)Trial: NCT06972732 2025-06-11 → 2026-10-01 (primary completion)Trial: NCT07187570 2025-06-03 → 2027-12-31 (primary completion)Trial: NCT06851962 2025-05-26 → 2026-06-30 (primary completion)Trial: NCT06611501 2025-05-22 → 2027-01-31 (primary completion)Trial: NCT07380841 2025-05-21 → 2025-11-11 (primary completion)Trial: NCT06979388 2025-05-20 → 2025-07-12 (primary completion)Trial: NCT06762964 2025-05-16 → 2027-02-28 (primary completion)Trial: NCT06668389 2025-05-12 → 2026-12-31 (primary completion)Trial: NCT06823856 2025-05-11 → 2025-05-21 (primary completion)Trial: NCT07018622 2025-05-07 → 2026-09-30 (primary completion)Trial: NCT06942910 2025-05-07 → 2026-07-31 (primary completion)Trial: NCT06982079 2025-05-01 → 2026-06-01 (primary completion)Trial: NCT06626737 2025-04-26 → 2025-12-31 (primary completion)Trial: NCT06919523 2025-04-15 → 2025-08-15 (primary completion)Trial: NCT06888050 2025-04-11 → 2026-06-30 (primary completion)Trial: NCT06871904 2025-04-07 → 2025-12-30 (primary completion)Trial: NCT06897605 2025-04-01 → 2025-10-31 (primary completion)Trial: NCT06792968 2025-03-30 → 2025-04-06 (primary completion)Trial: NCT06899061 2025-03-25 → 2026-02-03 (primary completion)Trial: NCT06920056 2025-03-24 → 2025-07-25 (primary completion)Trial: NCT06890143 2025-03-22 → 2026-12-31 (primary completion)Trial: NCT06887062 2025-03-21 → 2027-07-01 (primary completion)Trial: NCT06677060 2025-03-14 → 2029-12-17 (primary completion)Trial: NCT06932874 2025-03-04 → 2026-12-31 (primary completion)Trial: NCT06742723 2025-03-03 → 2029-12-18 (primary completion)Trial: NCT06785116 2025-03-02 → 2028-08-31 (primary completion)Trial: NCT06820567 2025-03-01 → 2026-03-01 (primary completion)Trial: NCT06845163 2025-02-08 → 2026-03-31 (primary completion)Trial: NCT07245069 2025-02-01 → 2028-11-30 (primary completion)Trial: NCT06638671 2025-01-31 → 2026-07-01 (primary completion)Trial: NCT06856369 2025-01-22 → 2026-02-14 (primary completion)Trial: NCT06778330 2025-01-20 → 2025-08-01 (primary completion)Trial: NCT06766500 2025-01-20 → 2025-02-28 (primary completion)Trial: NCT06174753 2025-01-20 → 2027-06-30 (primary completion)Trial: NCT06562582 2025-01-06 → 2027-12-31 (primary completion)Trial: NCT06759909 2025-01-03 → 2026-12-22 (primary completion)Trial: NCT06727838 2024-12-31 → 2025-01-25 (primary completion)Trial: NCT06759077 2024-12-28 → 2024-12-28 (primary completion)Trial: NCT07303556 2024-12-18 → 2025-07-01 (primary completion)Trial: NCT06763328 2024-12-16 → 2029-06-16 (primary completion)Trial: NCT06317051 2024-12-16 → 2026-07-31 (primary completion)Trial: NCT06740786 2024-12-10 → 2026-05-01 (primary completion)Trial: NCT06273072 2024-12-09 → 2026-09-30 (primary completion)Trial: NCT06748105 2024-12-01 → 2025-12-01 (primary completion)Trial: NCT06719661 2024-12-01 → 2025-05-05 (primary completion)Trial: NCT07058675 2024-11-25 → 2025-05-30 (primary completion)Trial: NCT06528405 2024-11-21 → 2027-07-31 (primary completion)Trial: NCT05828303 2024-11-15 → 2025-07-31 (primary completion)Trial: NCT06655220 2024-11-08 → 2024-12-08 (primary completion)Trial: NCT06654960 2024-11-05 → 2024-12-26 (primary completion)Trial: NCT06668753 2024-11-01 → 2026-09-30 (primary completion)Trial: NCT06427226 2024-10-31 → 2026-10-01 (primary completion)Trial: NCT07083232 2024-10-30 → 2024-10-30 (primary completion)Trial: NCT06612086 2024-10-25 → 2025-09-10 (primary completion)Trial: NCT06651021 2024-10-21 → 2024-10-28 (primary completion)Trial: NCT05989347 2024-10-15 → 2027-12-31 (primary completion)Trial: NCT06642272 2024-10-10 → 2028-12-31 (primary completion)Trial: NCT06405178 2024-09-30 → 2026-03-30 (primary completion)Trial: NCT05833958 2024-09-30 → 2025-09-30 (primary completion)Trial: NCT06589765 2024-09-27 → 2026-02-18 (primary completion)Trial: NCT06639087 2024-09-27 → 2025-05-29 (primary completion)Trial: NCT07555106 2024-09-15 → 2026-09-30 (primary completion)Trial: NCT05917587 2024-09-11 → 2027-12-31 (primary completion)Trial: NCT06491680 2024-09-10 → 2025-10-31 (primary completion)Trial: NCT06576375 2024-09-02 → 2025-01-31 (primary completion)Trial: NCT06373523 2024-09-01 → 2025-06-30 (primary completion)Trial: NCT06888505 2024-09-01 → 2025-09-01 (primary completion)Trial: NCT05435235 2024-09-01 → 2025-06-30 (primary completion)Trial: NCT06452498 2024-08-31 → 2028-04-30 (primary completion)Trial: NCT06012266 2024-08-31 → 2025-08-31 (primary completion)Trial: NCT06535529 2024-08-24 → 2025-08-01 (primary completion)Trial: NCT06610526 2024-08-23 → 2027-05-31 (primary completion)Trial: NCT06504862 2024-08-20 → 2024-10-03 (primary completion)Trial: NCT06783166 2024-08-15 → 2025-07-01 (primary completion)Trial: NCT06332612 2024-08-12 → 2024-12-30 (primary completion)Trial: NCT06510270 2024-08-01 → 2025-08-01 (primary completion)Trial: NCT06578520 2024-07-30 → 2025-12-01 (primary completion)Trial: NCT06233045 2024-07-23 → 2024-08-25 (primary completion)Trial: NCT06433479 2024-07-15 → 2025-07-01 (primary completion)Trial: NCT06915870 2024-07-12 → 2025-01-13 (primary completion)Trial: NCT06420167 2024-07-11 → 2026-04-30 (primary completion)Trial: NCT06532682 2024-07-01 → 2026-06-30 (primary completion)Trial: NCT06442280 2024-06-30 → 2026-01-31 (primary completion)Trial: NCT06459310 2024-06-30 → 2026-09-30 (primary completion)Trial: NCT06415773 2024-06-04 → 2025-06-13 (primary completion)Trial: NCT04887935 2024-06-04 → 2026-08-31 (primary completion)Trial: NCT06233201 2024-06-04 → 2024-07-14 (primary completion)Trial: NCT06111768 2024-05-30 → 2026-05-31 (primary completion)Trial: NCT06434025 2024-05-24 → 2026-05-24 (primary completion)Trial: NCT06244407 2024-05-23 → 2024-05-25 (primary completion)Trial: NCT06812429 2024-05-08 → 2025-04-05 (primary completion)Trial: NCT06263673 2024-05-07 → 2025-01-08 (primary completion)Trial: NCT06350123 2024-05-01 → 2025-05-09 (primary completion)Trial: NCT06233240 2024-04-30 → 2024-05-29 (primary completion)Trial: NCT06000462 2024-04-22 → 2025-08-30 (primary completion)Trial: NCT06772168 2024-04-19 → 2026-11-04 (primary completion)Trial: NCT06304857 2024-04-15 → 2026-12-31 (primary completion)Trial: NCT06307652 2024-04-12 → 2027-06-11 (primary completion)Trial: NCT05852704 2024-04-04 → 2027-12-04 (primary completion)Trial: NCT06256289 2024-03-31 → 2025-04-30 (primary completion)Trial: NCT06268873 2024-03-29 → 2028-02-24 (primary completion)Trial: NCT06364930 2024-03-26 → 2030-10-31 (primary completion)Trial: NCT05944016 2024-03-25 → 2026-09-30 (primary completion)Trial: NCT06327815 2024-03-15 → 2025-06-30 (primary completion)Trial: NCT06297681 2024-03-15 → 2025-01-30 (primary completion)Trial: NCT06398977 2024-03-11 → 2026-06-30 (primary completion)Trial: NCT05443932 2024-03-04 → 2024-12-31 (primary completion)Trial: NCT06365541 2024-03-01 → 2024-08-31 (primary completion)Trial: NCT06421870 2024-03-01 → 2025-05-31 (primary completion)Trial: NCT05886088 2024-02-29 → 2026-05-31 (primary completion)Trial: NCT06499948 2024-02-26 → 2025-11-21 (primary completion)Trial: NCT06269484 2024-02-15 → 2024-12-11 (primary completion)Trial: NCT06140537 2024-02-01 → 2028-10-31 (primary completion)Trial: NCT06711185 2024-01-30 → 2026-01-30 (primary completion)Trial: NCT06642623 2024-01-22 → 2029-09-30 (primary completion)Trial: NCT05719714 2024-01-16 → 2026-09-30 (primary completion)Trial: NCT07020377 2024-01-15 → 2025-12-20 (primary completion)Trial: NCT06192108 2024-01-10 → 2025-09-26 (primary completion)Trial: NCT06187493 2024-01-01 → 2025-01-31 (primary completion)Trial: NCT04640493 2023-12-31 → 2025-08-31 (primary completion)Trial: NCT06201000 2023-12-27 → 2024-07-01 (primary completion)Trial: NCT05914857 2023-12-20 → 2025-06-01 (primary completion)Trial: NCT06147518 2023-12-20 → 2024-12-31 (primary completion)Trial: NCT06572215 2023-12-14 → 2027-12-31 (primary completion)Trial: NCT06111443 2023-12-01 → 2026-11-30 (primary completion)Trial: NCT06113900 2023-12-01 → 2024-12-01 (primary completion)Trial: NCT05468203 2023-11-29 → 2025-07-18 (primary completion)Trial: NCT06142656 2023-11-25 → 2025-12-01 (primary completion)Trial: NCT05893225 2023-11-23 → 2027-02-28 (primary completion)Trial: NCT06901609 2023-11-22 → 2025-06-01 (primary completion)Trial: NCT05965440 2023-11-20 → 2026-02-02 (primary completion)Trial: NCT06226896 2023-11-15 → 2026-06-30 (primary completion)Trial: NCT06229795 2023-11-12 → 2024-11-12 (primary completion)Trial: NCT05741658 2023-11-08 → 2026-06-30 (primary completion)Trial: NCT06087835 2023-11-07 → 2027-02-18 (primary completion)Trial: NCT06107153 2023-11-01 → 2024-11-01 (primary completion)Trial: NCT06009874 2023-10-31 → 2026-08-31 (primary completion)Trial: NCT06054035 2023-10-26 → 2027-06-30 (primary completion)Trial: NCT05938712 2023-10-24 → 2027-10-01 (primary completion)Trial: NCT06247748 2023-10-19 → 2024-04-15 (primary completion)Trial: NCT06341842 2023-10-19 → 2025-04-19 (primary completion)FDA approval — 2002-01-25 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 075973) Sponsor: MYLAN.FDA approval — 2002-01-25 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 075965) Sponsor: EPIC PHARMA LLC.FDA approval (supplemental) — 2002-04-11 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075973 S-1) Sponsor: MYLAN. Class: Labeling.FDA approval (supplemental) — 2002-07-01 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 075965 S-1) Sponsor: EPIC PHARMA LLC. Class: Manufacturing (CMC).FDA approval (supplemental) — 2002-08-22 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075965 S-2) Sponsor: EPIC PHARMA LLC. Class: Labeling.FDA approval (supplemental) — 2002-10-02 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 075965 S-3) Sponsor: EPIC PHARMA LLC. Class: Manufacturing (CMC).FDA approval (supplemental) — 2002-10-11 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075973 S-2) Sponsor: MYLAN. Class: Labeling.FDA approval — 2003-09-11 FDA approved Riomet (metformin hydrochloride) (NDA 021591) Sponsor: RANBAXY. Class: Type 3 - New Dosage Form.FDA approval (supplemental) — 2004-06-02 FDA approved supplemental application for Riomet (metformin hydrochloride) — Labeling (NDA 021591 S-1) Sponsor: RANBAXY. Class: Labeling.FDA approval — 2005-01-14 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 077095) Sponsor: AUROBINDO.FDA approval (supplemental) — 2005-05-11 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075973 S-5) Sponsor: MYLAN. Class: Labeling.FDA approval — 2005-06-03 FDA approved Metformin Hydrochloride (metformin hydrochloride) (NDA 021748) Sponsor: SANTARUS INC. Class: Type 5 - New Formulation or New Manufacturer.FDA approval — 2005-08-29 FDA approved Actoplus Met (pioglitazone and metformin hydrochloride) (NDA 021842) Sponsor: TAKEDA PHARMS USA. Class: Type 4 - New Combination.FDA approval (supplemental) — 2005-09-20 FDA approved supplemental application for Riomet (metformin hydrochloride) — Labeling (NDA 021591 S-3) Sponsor: RANBAXY. Class: Labeling.FDA approval — 2005-10-28 FDA approved Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) (ANDA 077270) Sponsor: TEVA PHARMS.FDA approval — 2006-02-09 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 077336) Sponsor: SUN PHARM INDS (IN).FDA approval — 2006-06-05 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 077880) Sponsor: AMNEAL PHARMS NY.FDA approval (supplemental) — 2006-08-30 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-1) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2006-09-28 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-3) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2006-11-01 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (NDA 021748 S-2) Sponsor: SANTARUS INC. Class: Labeling.FDA approval (supplemental) — 2006-11-04 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-2) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2007-02-15 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077880 S-1) Sponsor: AMNEAL PHARMS NY. Class: Labeling.FDA approval (supplemental) — 2007-03-16 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077095 S-2) Sponsor: AUROBINDO. Class: Labeling.FDA approval — 2007-03-30 FDA approved Janumet (sitagliptin and metformin hydrochloride) (NDA 022044) Sponsor: MSD SUB MERCK. Class: Type 4 - New Combination.FDA approval (supplemental) — 2007-06-13 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075973 S-8) Sponsor: MYLAN. Class: Labeling.FDA approval (supplemental) — 2007-09-26 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-5) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2007-10-11 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 022044 S-1) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval (supplemental) — 2007-11-07 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077336 S-1) Sponsor: SUN PHARM INDS (IN). Class: Labeling.FDA approval — 2007-11-14 FDA approved Glyburide And Metformin Hydrochloride (glyburide and metformin hydrochloride) (ANDA 077870) Sponsor: AUROBINDO PHARMA.FDA approval (supplemental) — 2007-12-28 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (NDA 021748 S-4) Sponsor: SANTARUS INC. Class: Manufacturing (CMC).FDA approval (supplemental) — 2008-01-02 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-2) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2008-01-02 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-6) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2008-01-02 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-5) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2008-01-03 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 078596) Sponsor: AMNEAL PHARMS NY.FDA approval (supplemental) — 2008-02-26 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Efficacy (NDA 022044 S-4) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval (supplemental) — 2008-02-26 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Efficacy (NDA 022044 S-3) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval (supplemental) — 2008-02-29 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075973 S-9) Sponsor: MYLAN. Class: Labeling.FDA approval (supplemental) — 2008-03-20 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 077880 S-2) Sponsor: AMNEAL PHARMS NY. Class: Manufacturing (CMC).FDA approval — 2008-04-17 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 078321) Sponsor: CSPC OUYI.FDA approval (supplemental) — 2008-05-01 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 022044 S-7) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval (supplemental) — 2008-10-20 FDA approved supplemental application for Riomet (metformin hydrochloride) — Labeling (NDA 021591 S-4) Sponsor: RANBAXY. Class: Labeling.FDA approval (supplemental) — 2008-10-20 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-9) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2008-10-20 FDA approved Riomet (metformin hydrochloride) (NDA 021591) Sponsor: RANBAXY. Class: Type 3 - New Dosage Form.FDA approval (supplemental) — 2008-10-29 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077095 S-9) Sponsor: AUROBINDO. Class: Labeling.FDA approval (supplemental) — 2008-11-21 FDA approved supplemental application for Glyburide And Metformin Hydrochloride (glyburide and metformin hydrochloride) — Labeling (ANDA 077870 S-2) Sponsor: AUROBINDO PHARMA. Class: Labeling.FDA approval (supplemental) — 2009-01-04 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-7) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2009-01-15 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 077270 S-3) Sponsor: TEVA PHARMS. Class: Labeling.FDA approval (supplemental) — 2009-03-23 FDA approved supplemental application for Glyburide And Metformin Hydrochloride (glyburide and metformin hydrochloride) — Labeling (ANDA 077870 S-3) Sponsor: AUROBINDO PHARMA. Class: Labeling.FDA approval (supplemental) — 2009-05-12 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077095 S-8) Sponsor: AUROBINDO. Class: Labeling.FDA approval (supplemental) — 2009-05-12 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077095 S-6) Sponsor: AUROBINDO. Class: Labeling.FDA approval — 2009-06-03 FDA approved Glyburide-Metformin Hydrochloride (glyburide-metformin hydrochloride) (ANDA 079009) Sponsor: HERITAGE.FDA approval (supplemental) — 2009-06-16 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (NDA 021748 S-5) Sponsor: SANTARUS INC. Class: Labeling.FDA approval (supplemental) — 2009-09-14 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-9) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2009-10-21 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — REMS (NDA 021842 S-11) Sponsor: TAKEDA PHARMS USA. Class: REMS.FDA approval (supplemental) — 2009-12-28 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-11) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2010-01-19 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 077270 S-4) Sponsor: TEVA PHARMS. Class: Labeling.FDA approval (supplemental) — 2010-01-19 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 077270 S-5) Sponsor: TEVA PHARMS. Class: Labeling.FDA approval (supplemental) — 2010-02-25 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (NDA 021748 S-8) Sponsor: SANTARUS INC. Class: Labeling.FDA approval (supplemental) — 2010-02-26 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-13) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2010-02-26 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Efficacy (NDA 022044 S-12) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval (supplemental) — 2010-02-26 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Efficacy (NDA 022044 S-10) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval — 2010-04-22 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 090564) Sponsor: GRANULES INDIA.FDA approval (supplemental) — 2010-05-05 FDA approved supplemental application for Glyburide And Metformin Hydrochloride (glyburide and metformin hydrochloride) — Labeling (ANDA 077870 S-5) Sponsor: AUROBINDO PHARMA. Class: Labeling.FDA approval (supplemental) — 2010-05-20 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075965 S-12) Sponsor: EPIC PHARMA LLC. Class: Labeling.FDA approval (supplemental) — 2010-05-26 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 078596 S-4) Sponsor: AMNEAL PHARMS NY. Class: Labeling.FDA approval — 2010-06-23 FDA approved Glipizide And Metformin Hcl (glipizide and metformin hcl) (ANDA 078728) Sponsor: HERITAGE.FDA approval (supplemental) — 2010-08-06 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-12) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2010-09-24 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Efficacy (NDA 022044 S-14) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval (supplemental) — 2010-09-24 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-18) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2010-11-01 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 091184) Sponsor: ALKEM.FDA approval (supplemental) — 2010-11-19 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077336 S-4) Sponsor: SUN PHARM INDS (IN). Class: Labeling.FDA approval (supplemental) — 2010-12-06 FDA approved supplemental application for Riomet (metformin hydrochloride) — Labeling (NDA 021591 S-5) Sponsor: RANBAXY. Class: Labeling.FDA approval — 2011-01-31 FDA approved Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) (ANDA 078905) Sponsor: ZYDUS PHARMS USA INC.FDA approval (supplemental) — 2011-04-13 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (NDA 021748 S-10) Sponsor: SANTARUS INC. Class: Labeling.FDA approval (supplemental) — 2011-04-14 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-16) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2011-06-10 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-15) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2011-08-04 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — REMS (NDA 021842 S-14) Sponsor: TAKEDA PHARMS USA. Class: REMS.FDA approval (supplemental) — 2011-08-04 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-15) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval — 2012-01-18 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 201991) Sponsor: INVENTIA. Class: Not Applicable.FDA approval (supplemental) — 2012-01-26 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 090564 S-1) Sponsor: GRANULES INDIA. Class: Manufacturing (CMC).FDA approval — 2012-01-30 FDA approved Jentadueto (linagliptin and metformin hydrochloride) (NDA 201281) Sponsor: BOEHRINGER INGELHEIM. Class: Type 4 - New Combination.FDA approval — 2012-02-02 FDA approved Janumet Xr (sitagliptin and metformin hydrochloride) (NDA 202270) Sponsor: MSD SUB MERCK. Class: Type 3 - New Dosage Form.FDA approval (supplemental) — 2012-02-09 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 075973 S-15) Sponsor: MYLAN. Class: Manufacturing (CMC).FDA approval — 2012-03-12 FDA approved Metformin Hcl (metformin hcl) (ANDA 090888) Sponsor: MARKSANS PHARMA.FDA approval (supplemental) — 2012-03-24 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-22) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2012-04-17 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 077270 S-7) Sponsor: TEVA PHARMS. Class: Labeling.FDA approval (supplemental) — 2012-05-17 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — REMS (NDA 021842 S-16) Sponsor: TAKEDA PHARMS USA. Class: REMS.FDA approval (supplemental) — 2012-05-17 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-8) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2012-05-17 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Efficacy (NDA 021842 S-10) Sponsor: TAKEDA PHARMS USA. Class: Efficacy.FDA approval — 2012-07-20 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 079118) Sponsor: AUROBINDO PHARMA LTD.FDA approval — 2012-08-01 FDA approved Metformin Hydrochloride (metformin) (ANDA 200690) Sponsor: MYLAN PHARMS INC. Class: Not Applicable.FDA approval (supplemental) — 2012-09-19 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 078596 S-7) Sponsor: AMNEAL PHARMS NY. Class: Manufacturing (CMC).FDA approval (supplemental) — 2012-09-25 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-2) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2012-10-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 091184 S-3) Sponsor: ALKEM. Class: Manufacturing (CMC).FDA approval (supplemental) — 2012-10-18 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-2) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2012-10-18 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-26) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2013-01-25 FDA approved Kazano (alogliptin and metformin hydrochloride) (NDA 203414) Sponsor: TAKEDA PHARMS USA. Class: Type 4 - New Combination.FDA approval (supplemental) — 2013-02-07 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-27) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2013-02-11 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-3) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2013-02-13 FDA approved Pioglitazone Hcl And Metformin Hcl (pioglitazone hcl and metformin hcl) (ANDA 202001) Sponsor: TORRENT PHARMS LTD. Class: Not Applicable.FDA approval — 2013-02-13 FDA approved Pioglitazone Hydrochloride And Metformin Hydrochloride (pioglitazone hydrochloride and metformin hydrochloride) (ANDA 200823) Sponsor: AUROBINDO PHARMA LTD. Class: Not Applicable.FDA approval (supplemental) — 2013-04-10 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 202270 S-1) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval (supplemental) — 2013-06-18 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-3) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2013-06-28 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 022044 S-28) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval — 2013-07-19 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 091664) Sponsor: LUPIN. Class: Not Applicable.FDA approval (supplemental) — 2013-07-19 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 202270 S-4) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval (supplemental) — 2013-08-15 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Manufacturing (CMC) (NDA 021842 S-18) Sponsor: TAKEDA PHARMS USA. Class: Manufacturing (CMC).FDA approval (supplemental) — 2013-09-05 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Efficacy (NDA 201281 S-4) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2013-09-11 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-29) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2013-09-11 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 203769) Sponsor: SCIEGEN PHARMS.FDA approval (supplemental) — 2013-09-16 FDA approved supplemental application for Riomet (metformin hydrochloride) — Manufacturing (CMC) (NDA 021591 S-6) Sponsor: RANBAXY. Class: Manufacturing (CMC).FDA approval (supplemental) — 2013-10-17 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 202270 S-5) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval (supplemental) — 2013-10-17 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 203414 S-1) Sponsor: TAKEDA PHARMS USA. Class: Manufacturing (CMC).FDA approval (supplemental) — 2013-12-18 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 201281 S-5) Sponsor: BOEHRINGER INGELHEIM. Class: Manufacturing (CMC).FDA approval — 2014-01-08 FDA approved Farxiga (dapagliflozin) (NDA 202293) Sponsor: ASTRAZENECA AB. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2014-02-12 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-6) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2014-03-18 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 022044 S-30) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval (supplemental) — 2014-03-20 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 203769 S-1) Sponsor: SCIEGEN PHARMS. Class: Manufacturing (CMC).FDA approval (supplemental) — 2014-05-22 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-7) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2014-06-17 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075973 S-11) Sponsor: MYLAN. Class: Labeling.FDA approval (supplemental) — 2014-07-30 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Efficacy (NDA 201281 S-6) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2014-07-31 FDA approved supplemental application for Farxiga (dapagliflozin) — Manufacturing (CMC) (NDA 202293 S-1) Sponsor: ASTRAZENECA AB. Class: Manufacturing (CMC).FDA approval (supplemental) — 2014-08-08 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-3) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval — 2014-08-08 FDA approved Invokamet (canagliflozin and metformin hydrochloride) (NDA 204353) Sponsor: JANSSEN PHARMS. Class: Type 4 - New Combination.FDA approval (supplemental) — 2014-08-16 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-19) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2014-08-21 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 203414 S-4) Sponsor: TAKEDA PHARMS USA. Class: Manufacturing (CMC).FDA approval — 2014-08-28 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 203686) Sponsor: ZYDUS HLTHCARE.FDA approval (supplemental) — 2014-08-29 FDA approved supplemental application for Riomet (metformin hydrochloride) — Manufacturing (CMC) (NDA 021591 S-8) Sponsor: RANBAXY. Class: Manufacturing (CMC).FDA approval (supplemental) — 2014-09-19 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 202270 S-8) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval — 2014-10-29 FDA approved Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) (NDA 205649) Sponsor: ASTRAZENECA AB. Class: Type 4 - New Combination.FDA approval (supplemental) — 2014-12-02 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 203769 S-3) Sponsor: SCIEGEN PHARMS. Class: Manufacturing (CMC).FDA approval (supplemental) — 2014-12-22 FDA approved supplemental application for Metformin Hcl (metformin hcl) — Manufacturing (CMC) (ANDA 090888 S-1) Sponsor: MARKSANS PHARMA. Class: Manufacturing (CMC).FDA approval (supplemental) — 2015-01-05 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 022044 S-32) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval (supplemental) — 2015-02-18 FDA approved supplemental application for Glyburide And Metformin Hydrochloride (glyburide and metformin hydrochloride) — Labeling (ANDA 077870 S-6) Sponsor: AUROBINDO PHARMA. Class: Labeling.FDA approval (supplemental) — 2015-02-18 FDA approved supplemental application for Glyburide-Metformin Hydrochloride (glyburide-metformin hydrochloride) — Labeling (ANDA 079009 S-3) Sponsor: HERITAGE. Class: Labeling.FDA approval (supplemental) — 2015-02-18 FDA approved supplemental application for Glyburide And Metformin Hydrochloride (glyburide and metformin hydrochloride) — Labeling (ANDA 077870 S-13) Sponsor: AUROBINDO PHARMA. Class: Labeling.FDA approval (supplemental) — 2015-02-25 FDA approved supplemental application for Pioglitazone Hydrochloride And Metformin Hydrochloride (pioglitazone hydrochloride and metformin hydrochloride) — Labeling (ANDA 200823 S-5) Sponsor: AUROBINDO PHARMA LTD. Class: Labeling.FDA approval (supplemental) — 2015-03-03 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-2) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2015-03-11 FDA approved supplemental application for Farxiga (dapagliflozin) — Efficacy (NDA 202293 S-2) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2015-04-13 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203686 S-2) Sponsor: ZYDUS HLTHCARE. Class: Labeling.FDA approval (supplemental) — 2015-04-27 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-34) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2015-04-27 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-9) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2015-06-02 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 078905 S-1) Sponsor: ZYDUS PHARMS USA INC. Class: Labeling.FDA approval (supplemental) — 2015-06-02 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 078905 S-2) Sponsor: ZYDUS PHARMS USA INC. Class: Labeling.FDA approval (supplemental) — 2015-06-08 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 204353 S-4) Sponsor: JANSSEN PHARMS. Class: Manufacturing (CMC).FDA approval (supplemental) — 2015-06-12 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 022044 S-33) Sponsor: MSD SUB MERCK. Class: Manufacturing (CMC).FDA approval (supplemental) — 2015-07-28 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-8) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2015-08-17 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 077270 S-9) Sponsor: TEVA PHARMS. Class: Labeling.FDA approval — 2015-08-26 FDA approved Synjardy (empagliflozin and metformin hydrochloride) (NDA 206111) Sponsor: BOEHRINGER INGELHEIM. Class: Type 4 - New Combination.FDA approval (supplemental) — 2015-08-28 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-35) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2015-08-28 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-10) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2015-08-28 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Labeling (NDA 203414 S-5) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2015-08-28 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-10) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2015-09-01 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 205649 S-1) Sponsor: ASTRAZENECA AB. Class: Manufacturing (CMC).FDA approval (supplemental) — 2015-09-10 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Efficacy (NDA 204353 S-3) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2015-09-18 FDA approved supplemental application for Pioglitazone Hcl And Metformin Hcl (pioglitazone hcl and metformin hcl) — Labeling (ANDA 202001 S-5) Sponsor: TORRENT PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2015-09-18 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 201281 S-9) Sponsor: BOEHRINGER INGELHEIM. Class: Manufacturing (CMC).FDA approval (supplemental) — 2015-09-18 FDA approved supplemental application for Pioglitazone Hcl And Metformin Hcl (pioglitazone hcl and metformin hcl) — Labeling (ANDA 202001 S-4) Sponsor: TORRENT PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2015-09-28 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077336 S-7) Sponsor: SUN PHARM INDS (IN). Class: Labeling.FDA approval (supplemental) — 2015-10-27 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (NDA 021748 S-19) Sponsor: SANTARUS INC. Class: Manufacturing (CMC).FDA approval — 2015-11-05 FDA approved Pioglitazone And Metformin Hydrochloride (pioglitazone and metformin hydrochloride) (ANDA 204802) Sponsor: MACLEODS PHARMS LTD.FDA approval (supplemental) — 2015-12-04 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-8) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2015-12-04 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-2) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2015-12-04 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-12) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2015-12-04 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-3) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2015-12-23 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 204353 S-7) Sponsor: JANSSEN PHARMS. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-01-06 FDA approved supplemental application for Farxiga (dapagliflozin) — Manufacturing (CMC) (NDA 202293 S-7) Sponsor: ASTRAZENECA AB. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-01-12 FDA approved supplemental application for Farxiga (dapagliflozin) — Manufacturing (CMC) (NDA 202293 S-6) Sponsor: ASTRAZENECA AB. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-01-12 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 205649 S-2) Sponsor: ASTRAZENECA AB. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-02-11 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 201281 S-11) Sponsor: BOEHRINGER INGELHEIM. Class: Manufacturing (CMC).FDA approval — 2016-02-29 FDA approved Glyburide And Metformin Hydrochloride (glyburide and metformin hydrochloride) (ANDA 206748) Sponsor: ZYDUS PHARMS.FDA approval (supplemental) — 2016-03-07 FDA approved supplemental application for Metformin Hydrochloride (metformin) — Manufacturing (CMC) (ANDA 200690 S-2) Sponsor: MYLAN PHARMS INC. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-03-17 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 204353 S-8) Sponsor: JANSSEN PHARMS. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-03-28 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-10) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2016-04-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 090564 S-5) Sponsor: GRANULES INDIA. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-04-05 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Efficacy (NDA 203414 S-3) Sponsor: TAKEDA PHARMS USA. Class: Efficacy.FDA approval (supplemental) — 2016-04-14 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 204353 S-11) Sponsor: JANSSEN PHARMS. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-04-29 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 201281 S-12) Sponsor: BOEHRINGER INGELHEIM. Class: Manufacturing (CMC).FDA approval — 2016-04-29 FDA approved Metformin Hydrochloride Extended Release (metformin hydrochloride) (ANDA 090295) Sponsor: MARKSANS PHARMA.FDA approval (supplemental) — 2016-05-06 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 206111 S-8) Sponsor: BOEHRINGER INGELHEIM. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-05-12 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 078321 S-3) Sponsor: CSPC OUYI. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-05-20 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-15) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2016-05-20 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Efficacy (NDA 204353 S-6) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval — 2016-05-27 FDA approved Jentadueto Xr (linagliptin and metformin hydrochloride) (NDA 208026) Sponsor: BOEHRINGER INGELHEIM. Class: Type 4 - New Combination.FDA approval (supplemental) — 2016-06-14 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-4) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2016-06-14 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-9) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2016-07-08 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-9) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2016-07-08 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Efficacy (NDA 206111 S-1) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2016-07-08 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-6) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval — 2016-07-11 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 205096) Sponsor: CSPC OUYI.FDA approval — 2016-08-01 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 202917) Sponsor: SUN PHARM.FDA approval (supplemental) — 2016-08-17 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-5) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2016-08-17 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-10) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2016-08-17 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-20) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval — 2016-09-20 FDA approved Invokamet Xr (canagliflozin and metformin hydrochloride) (NDA 205879) Sponsor: JANSSEN PHARMS. Class: Type 4 - New Combination.FDA approval (supplemental) — 2016-11-23 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 204353 S-19) Sponsor: JANSSEN PHARMS. Class: Manufacturing (CMC).FDA approval — 2016-12-07 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 206955) Sponsor: MACLEODS PHARMS LTD.FDA approval — 2016-12-09 FDA approved Synjardy Xr (empagliflozin, metformin hydrochloride) (NDA 208658) Sponsor: BOEHRINGER INGELHEIM. Class: Type 3 - New Dosage Form.FDA approval (supplemental) — 2016-12-12 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Efficacy (NDA 021842 S-20) Sponsor: TAKEDA PHARMS USA. Class: Efficacy.FDA approval (supplemental) — 2016-12-12 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Labeling (NDA 203414 S-8) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2016-12-12 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-21) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2016-12-12 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Labeling (NDA 203414 S-9) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval — 2016-12-13 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 207427) Sponsor: REGCON HOLDINGS.FDA approval (supplemental) — 2016-12-14 FDA approved supplemental application for Pioglitazone And Metformin Hydrochloride (pioglitazone and metformin hydrochloride) — Manufacturing (CMC) (ANDA 204802 S-4) Sponsor: MACLEODS PHARMS LTD. Class: Manufacturing (CMC).FDA approval (supplemental) — 2016-12-23 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Efficacy (NDA 208658 S-1) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2016-12-23 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Efficacy (NDA 206111 S-4) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2016-12-23 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-18) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2016-12-23 FDA approved supplemental application for Jentadueto Xr (linagliptin and metformin hydrochloride) — Labeling (NDA 208026 S-4) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2016-12-23 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-14) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2017-01-10 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 205649 S-7) Sponsor: ASTRAZENECA AB. Class: Manufacturing (CMC).FDA approval (supplemental) — 2017-01-18 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-16) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2017-01-18 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-40) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2017-01-18 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-39) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2017-01-18 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-15) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2017-02-01 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Efficacy (NDA 204353 S-14) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2017-02-15 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Labeling (NDA 203414 S-7) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval — 2017-02-23 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 202306) Sponsor: PLATINUM.FDA approval (supplemental) — 2017-03-01 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-6) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2017-03-01 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-11) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2017-03-14 FDA approved supplemental application for Jentadueto Xr (linagliptin and metformin hydrochloride) — Labeling (NDA 208026 S-3) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2017-03-14 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-17) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2017-04-04 FDA approved supplemental application for Glipizide And Metformin Hcl (glipizide and metformin hcl) — Labeling (ANDA 078728 S-2) Sponsor: HERITAGE. Class: Labeling.FDA approval (supplemental) — 2017-04-05 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 078905 S-3) Sponsor: ZYDUS PHARMS USA INC. Class: Labeling.FDA approval (supplemental) — 2017-04-05 FDA approved supplemental application for Glipizide And Metformin Hcl (glipizide and metformin hcl) — Labeling (ANDA 078728 S-5) Sponsor: HERITAGE. Class: Labeling.FDA approval (supplemental) — 2017-04-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (NDA 021748 S-20) Sponsor: SANTARUS INC. Class: Labeling.FDA approval (supplemental) — 2017-04-05 FDA approved supplemental application for Glipizide And Metformin Hydrochloride (glipizide and metformin hydrochloride) — Labeling (ANDA 077270 S-11) Sponsor: TEVA PHARMS. Class: Labeling.FDA approval (supplemental) — 2017-04-05 FDA approved supplemental application for Riomet (metformin hydrochloride) — Labeling (NDA 021591 S-10) Sponsor: RANBAXY. Class: Labeling.FDA approval (supplemental) — 2017-07-25 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Labeling (NDA 205879 S-5) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2017-07-25 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-23) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2017-07-28 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Manufacturing (CMC) (NDA 205649 S-8) Sponsor: ASTRAZENECA AB. Class: Manufacturing (CMC).FDA approval (supplemental) — 2017-08-10 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-17) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2017-08-10 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-19) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2017-08-10 FDA approved supplemental application for Jentadueto Xr (linagliptin and metformin hydrochloride) — Labeling (NDA 208026 S-5) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2017-08-10 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-42) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2017-08-11 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-24) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2017-08-11 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Labeling (NDA 205879 S-6) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2017-08-14 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 090564 S-13) Sponsor: GRANULES INDIA. Class: Labeling.FDA approval (supplemental) — 2017-08-14 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 090564 S-12) Sponsor: GRANULES INDIA. Class: Manufacturing (CMC).FDA approval (supplemental) — 2017-10-20 FDA approved supplemental application for Farxiga (dapagliflozin) — Efficacy (NDA 202293 S-12) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval — 2017-10-31 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 205330) Sponsor: AARXION ANDA HLDING.FDA approval (supplemental) — 2017-12-13 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-15) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2017-12-13 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-4) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval — 2017-12-19 FDA approved Segluromet (ertugliflozin and metformin hydrochloride) (NDA 209806) Sponsor: MSD SUB MERCK. Class: Type 4 - New Combination.FDA approval (supplemental) — 2017-12-21 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-22) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval — 2017-12-26 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 203832) Sponsor: MPP PHARMA.FDA approval (supplemental) — 2018-01-02 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Efficacy (NDA 205879 S-2) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2018-02-09 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-18) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2018-02-09 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-43) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2018-03-16 FDA approved Metformin Er 500 Mg (metformin er 500 mg) (ANDA 209313) Sponsor: GRANULES.FDA approval — 2018-08-27 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 209882) Sponsor: LAURUS.FDA approval — 2018-09-24 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 211052) Sponsor: YICHANG HUMANWELL.FDA approval — 2018-10-22 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 206145) Sponsor: ALKEM LABS LTD.FDA approval (supplemental) — 2018-10-26 FDA approved supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) — Labeling (NDA 209806 S-1) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2018-10-26 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Labeling (NDA 205879 S-9) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2018-10-26 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-31) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2018-10-26 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-6) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2018-10-26 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-17) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2018-10-26 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-18) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2018-10-26 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-10) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2018-10-29 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Efficacy (NDA 204353 S-25) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2018-10-29 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Efficacy (NDA 205879 S-7) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval — 2018-11-02 FDA approved Metformin (metformin) (ANDA 209674) Sponsor: NOVAST LABS.FDA approval (supplemental) — 2018-11-06 FDA approved supplemental application for Riomet (metformin hydrochloride) — Labeling (NDA 021591 S-7) Sponsor: RANBAXY. Class: Labeling.FDA approval (supplemental) — 2018-11-07 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (NDA 021748 S-25) Sponsor: SANTARUS INC. Class: Labeling.FDA approval — 2018-12-27 FDA approved Metformin Hydrochloride (metformin hydrochloride extended-release tablets) (ANDA 209993) Sponsor: QINGDAO BAHEAL PHARM.FDA approval (supplemental) — 2019-01-02 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 078321 S-4) Sponsor: CSPC OUYI. Class: Labeling.FDA approval (supplemental) — 2019-01-02 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 078321 S-7) Sponsor: CSPC OUYI. Class: Labeling.FDA approval (supplemental) — 2019-01-02 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 079118 S-9) Sponsor: AUROBINDO PHARMA LTD. Class: Labeling.FDA approval (supplemental) — 2019-01-02 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 079118 S-8) Sponsor: AUROBINDO PHARMA LTD. Class: Labeling.FDA approval (supplemental) — 2019-01-14 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075973 S-19) Sponsor: MYLAN. Class: Labeling.FDA approval (supplemental) — 2019-01-14 FDA approved supplemental application for Metformin Er 500 Mg (metformin er 500 mg) — Labeling (ANDA 209313 S-1) Sponsor: GRANULES. Class: Labeling.FDA approval (supplemental) — 2019-01-14 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075973 S-20) Sponsor: MYLAN. Class: Labeling.FDA approval (supplemental) — 2019-02-02 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 091184 S-12) Sponsor: ALKEM. Class: Labeling.FDA approval (supplemental) — 2019-02-02 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 091184 S-10) Sponsor: ALKEM. Class: Labeling.FDA approval (supplemental) — 2019-02-14 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077095 S-23) Sponsor: AUROBINDO. Class: Labeling.FDA approval (supplemental) — 2019-02-14 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077095 S-24) Sponsor: AUROBINDO. Class: Labeling.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203769 S-9) Sponsor: SCIEGEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Pioglitazone Hydrochloride And Metformin Hydrochloride (pioglitazone hydrochloride and metformin hydrochloride) — Labeling (ANDA 200823 S-10) Sponsor: AUROBINDO PHARMA LTD. Class: Labeling.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203769 S-12) Sponsor: SCIEGEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Pioglitazone Hydrochloride And Metformin Hydrochloride (pioglitazone hydrochloride and metformin hydrochloride) — Labeling (ANDA 200823 S-9) Sponsor: AUROBINDO PHARMA LTD. Class: Labeling.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Metformin Hcl (metformin hcl) — Labeling (ANDA 090888 S-4) Sponsor: MARKSANS PHARMA. Class: Labeling.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 090564 S-15) Sponsor: GRANULES INDIA. Class: Labeling.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Pioglitazone Hydrochloride And Metformin Hydrochloride (pioglitazone hydrochloride and metformin hydrochloride) — Labeling (ANDA 200823 S-7) Sponsor: AUROBINDO PHARMA LTD. Class: Labeling.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Farxiga (dapagliflozin) — Efficacy (NDA 202293 S-15) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2019-02-22 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Efficacy (NDA 205649 S-9) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2019-03-01 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077336 S-15) Sponsor: SUN PHARM INDS (IN). Class: Labeling.FDA approval (supplemental) — 2019-03-01 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077336 S-12) Sponsor: SUN PHARM INDS (IN). Class: Labeling.FDA approval (supplemental) — 2019-03-06 FDA approved supplemental application for Pioglitazone And Metformin Hydrochloride (pioglitazone and metformin hydrochloride) — Labeling (ANDA 204802 S-8) Sponsor: MACLEODS PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2019-03-06 FDA approved supplemental application for Pioglitazone And Metformin Hydrochloride (pioglitazone and metformin hydrochloride) — Labeling (ANDA 204802 S-5) Sponsor: MACLEODS PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2019-04-17 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 206955 S-12) Sponsor: MACLEODS PHARMS LTD. Class: Manufacturing (CMC).FDA approval (supplemental) — 2019-07-01 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-20) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2019-07-01 FDA approved supplemental application for Jentadueto Xr (linagliptin and metformin hydrochloride) — Labeling (NDA 208026 S-13) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2019-07-01 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-25) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2019-07-01 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-47) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2019-07-01 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Labeling (NDA 203414 S-12) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2019-07-03 FDA approved supplemental application for Jentadueto Xr (linagliptin and metformin hydrochloride) — Efficacy (NDA 208026 S-8) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2019-07-03 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Efficacy (NDA 201281 S-22) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2019-07-22 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 202917 S-7) Sponsor: SUN PHARM. Class: Manufacturing (CMC).FDA approval (supplemental) — 2019-08-12 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Efficacy (NDA 202270 S-19) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval (supplemental) — 2019-08-12 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Efficacy (NDA 022044 S-46) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval (supplemental) — 2019-08-27 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 202306 S-1) Sponsor: PLATINUM. Class: Labeling.FDA approval (supplemental) — 2019-08-27 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 078596 S-17) Sponsor: AMNEAL PHARMS NY. Class: Labeling.FDA approval (supplemental) — 2019-08-27 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077880 S-22) Sponsor: AMNEAL PHARMS NY. Class: Labeling.FDA approval (supplemental) — 2019-08-27 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 077880 S-21) Sponsor: AMNEAL PHARMS NY. Class: Labeling.FDA approval (supplemental) — 2019-08-27 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 078596 S-15) Sponsor: AMNEAL PHARMS NY. Class: Labeling.FDA approval (supplemental) — 2019-08-27 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 202306 S-2) Sponsor: PLATINUM. Class: Labeling.FDA approval (supplemental) — 2019-08-28 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075965 S-17) Sponsor: EPIC PHARMA LLC. Class: Labeling.FDA approval (supplemental) — 2019-08-28 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 075965 S-18) Sponsor: EPIC PHARMA LLC. Class: Labeling.FDA approval (supplemental) — 2019-09-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 091664 S-6) Sponsor: LUPIN. Class: Labeling.FDA approval (supplemental) — 2019-09-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 091664 S-2) Sponsor: LUPIN. Class: Labeling.FDA approval (supplemental) — 2019-10-18 FDA approved supplemental application for Farxiga (dapagliflozin) — Efficacy (NDA 202293 S-18) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2019-10-18 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Efficacy (NDA 205649 S-11) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2019-11-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 205330 S-4) Sponsor: AARXION ANDA HLDING. Class: Labeling.FDA approval (supplemental) — 2019-11-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 206955 S-10) Sponsor: MACLEODS PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2019-11-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 206955 S-3) Sponsor: MACLEODS PHARMS LTD. Class: Labeling.FDA approval — 2019-11-25 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 212969) Sponsor: GLENMARK PHARMS LTD.FDA approval (supplemental) — 2020-01-24 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-36) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2020-01-24 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-9) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2020-01-24 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-13) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2020-01-24 FDA approved supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) — Labeling (NDA 209806 S-2) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2020-01-24 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Labeling (NDA 205879 S-14) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2020-01-24 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-21) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2020-01-24 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-22) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2020-01-27 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Efficacy (NDA 205879 S-11) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval — 2020-01-27 FDA approved Trijardy Xr (empagliflozin, linagliptin, metformin hydrochloride) (NDA 212614) Sponsor: BOEHRINGER INGELHEIM. Class: Type 4 - New Combination.FDA approval (supplemental) — 2020-01-27 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Efficacy (NDA 204353 S-33) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2020-02-03 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-14) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2020-02-03 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-22) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2020-02-21 FDA approved supplemental application for Pioglitazone Hcl And Metformin Hcl (pioglitazone hcl and metformin hcl) — Labeling (ANDA 202001 S-11) Sponsor: TORRENT PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2020-02-21 FDA approved supplemental application for Pioglitazone Hcl And Metformin Hcl (pioglitazone hcl and metformin hcl) — Labeling (ANDA 202001 S-10) Sponsor: TORRENT PHARMS LTD. Class: Labeling.FDA approval — 2020-03-03 FDA approved Metformin Hydrochloride Oral Solution (metformin hydrochloride) (ANDA 211309) Sponsor: SAPTALIS PHARMS.FDA approval (supplemental) — 2020-03-30 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Efficacy (NDA 201281 S-24) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2020-03-30 FDA approved supplemental application for Jentadueto Xr (linagliptin and metformin hydrochloride) — Efficacy (NDA 208026 S-12) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval — 2020-04-09 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 213651) Sponsor: AJANTA PHARMA LTD.FDA approval (supplemental) — 2020-05-05 FDA approved supplemental application for Farxiga (dapagliflozin) — Efficacy (NDA 202293 S-20) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2020-05-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203769 S-18) Sponsor: SCIEGEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2020-08-18 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Efficacy (NDA 205879 S-17) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2020-08-18 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Efficacy (NDA 204353 S-39) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2020-10-30 FDA approved supplemental application for Trijardy Xr (empagliflozin, linagliptin, metformin hydrochloride) — Efficacy (NDA 212614 S-4) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2020-12-04 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Efficacy (NDA 022044 S-48) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval (supplemental) — 2020-12-04 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Efficacy (NDA 202270 S-22) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval — 2021-01-14 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 213344) Sponsor: GRANULES.FDA approval — 2021-03-09 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 213962) Sponsor: AJANTA PHARMA LTD.FDA approval — 2021-04-16 FDA approved Metformin Hydrochloride (metformin hydrochloride extended-release tablets) (ANDA 213334) Sponsor: SCIEGEN PHARMS.FDA approval (supplemental) — 2021-04-30 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203686 S-10) Sponsor: ZYDUS HLTHCARE. Class: Labeling.FDA approval (supplemental) — 2021-04-30 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203686 S-6) Sponsor: ZYDUS HLTHCARE. Class: Labeling.FDA approval (supplemental) — 2021-04-30 FDA approved supplemental application for Farxiga (dapagliflozin) — Efficacy (NDA 202293 S-24) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2021-04-30 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203686 S-9) Sponsor: ZYDUS HLTHCARE. Class: Labeling.FDA approval (supplemental) — 2021-05-17 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 209882 S-6) Sponsor: LAURUS. Class: Manufacturing (CMC).FDA approval (supplemental) — 2021-06-11 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-26) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2021-06-11 FDA approved supplemental application for Trijardy Xr (empagliflozin, linagliptin, metformin hydrochloride) — Labeling (NDA 212614 S-10) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2021-06-11 FDA approved supplemental application for Trijardy Xr (empagliflozin, linagliptin, metformin hydrochloride) — Labeling (NDA 212614 S-8) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2021-06-11 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-13) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2021-06-11 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-15) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2021-06-11 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-25) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2021-06-25 FDA approved supplemental application for Metformin Hydrochloride Extended Release (metformin hydrochloride) — Labeling (ANDA 090295 S-2) Sponsor: MARKSANS PHARMA. Class: Labeling.FDA approval (supplemental) — 2021-06-25 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203832 S-4) Sponsor: MPP PHARMA. Class: Labeling.FDA approval (supplemental) — 2021-06-25 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 203832 S-3) Sponsor: MPP PHARMA. Class: Labeling.FDA approval (supplemental) — 2021-06-25 FDA approved supplemental application for Metformin Hydrochloride Extended Release (metformin hydrochloride) — Labeling (ANDA 090295 S-3) Sponsor: MARKSANS PHARMA. Class: Labeling.FDA approval (supplemental) — 2021-06-28 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 205096 S-6) Sponsor: CSPC OUYI. Class: Labeling.FDA approval (supplemental) — 2021-06-28 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 205096 S-2) Sponsor: CSPC OUYI. Class: Labeling.FDA approval — 2021-08-11 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 213359) Sponsor: UNICHEM.FDA approval (supplemental) — 2021-09-17 FDA approved supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) — Efficacy (NDA 209806 S-6) Sponsor: MSD SUB MERCK. Class: Efficacy.FDA approval (supplemental) — 2021-10-01 FDA approved supplemental application for Jentadueto Xr (linagliptin and metformin hydrochloride) — Labeling (NDA 208026 S-20) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2021-11-04 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-51) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2021-11-04 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-25) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2021-12-03 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 213320) Sponsor: HARMAN FINOCHEM.FDA approval (supplemental) — 2022-02-03 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Efficacy (NDA 205649 S-16) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval — 2022-02-22 FDA approved Metformin Hydrochloride (metformin hydrochloride extended-release tablets) (ANDA 214629) Sponsor: SCIEGEN PHARMS.FDA approval (supplemental) — 2022-03-02 FDA approved supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) — Labeling (NDA 209806 S-8) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2022-03-11 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Labeling (NDA 203414 S-13) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval (supplemental) — 2022-03-21 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-31) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2022-03-21 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-17) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2022-04-11 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Efficacy (NDA 205649 S-17) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2022-04-15 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Labeling (NDA 201281 S-31) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval — 2022-06-09 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 212681) Sponsor: PRINSTON INC.FDA approval (supplemental) — 2022-06-21 FDA approved supplemental application for Janumet Xr (sitagliptin and metformin hydrochloride) — Labeling (NDA 202270 S-26) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2022-06-21 FDA approved supplemental application for Janumet (sitagliptin and metformin hydrochloride) — Labeling (NDA 022044 S-52) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval — 2022-08-19 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 212677) Sponsor: VISTAPHARM LLC.FDA approval (supplemental) — 2022-10-13 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-23) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2022-10-13 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Labeling (NDA 205879 S-18) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2022-10-13 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-41) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2022-10-13 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-36) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2022-10-13 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-28) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2022-10-13 FDA approved supplemental application for Trijardy Xr (empagliflozin, linagliptin, metformin hydrochloride) — Labeling (NDA 212614 S-16) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2022-10-13 FDA approved supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) — Labeling (NDA 209806 S-9) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2022-10-13 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-18) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval — 2023-01-10 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 212448) Sponsor: MICRO LABS.FDA approval (supplemental) — 2023-02-06 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Efficacy (NDA 208658 S-21) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2023-02-06 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Efficacy (NDA 206111 S-33) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2023-02-17 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-27) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2023-05-08 FDA approved supplemental application for Farxiga (dapagliflozin) — Efficacy (NDA 202293 S-26) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2023-05-26 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 213320 S-2) Sponsor: HARMAN FINOCHEM. Class: Manufacturing (CMC).FDA approval (supplemental) — 2023-06-07 FDA approved supplemental application for Pioglitazone And Metformin Hydrochloride (pioglitazone and metformin hydrochloride) — Labeling (ANDA 204802 S-24) Sponsor: MACLEODS PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2023-06-07 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 205330 S-11) Sponsor: AARXION ANDA HLDING. Class: Labeling.FDA approval (supplemental) — 2023-06-07 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 206955 S-25) Sponsor: MACLEODS PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2023-06-20 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-39) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2023-06-20 FDA approved supplemental application for Jentadueto (linagliptin and metformin hydrochloride) — Efficacy (NDA 201281 S-35) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2023-06-20 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Efficacy (NDA 206111 S-38) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval — 2023-06-20 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 215629) Sponsor: SENORES PHARMS.FDA approval (supplemental) — 2023-06-20 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Efficacy (NDA 208658 S-26) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2023-06-20 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-25) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2023-06-20 FDA approved supplemental application for Jentadueto Xr (linagliptin and metformin hydrochloride) — Efficacy (NDA 208026 S-24) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2023-07-05 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Labeling (NDA 205879 S-19) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2023-07-05 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-42) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2023-07-27 FDA approved supplemental application for Kazano (alogliptin and metformin hydrochloride) — Efficacy (NDA 203414 S-16) Sponsor: TAKEDA PHARMS USA. Class: Efficacy.FDA approval — 2023-07-31 FDA approved Saxagliptin (saxagliptin) (ANDA 205980) Sponsor: MYLAN.FDA approval — 2023-07-31 FDA approved Saxagliptin And Metformin (saxagliptin and metformin) (ANDA 205981) Sponsor: MYLAN.FDA approval — 2023-08-09 FDA approved Saxagliptin And Metformin Hydrochloride (saxagliptin and metformin hydrochloride) (ANDA 207678) Sponsor: DR REDDYS LABS SA.FDA approval (supplemental) — 2023-09-12 FDA approved supplemental application for Farxiga (dapagliflozin) — Labeling (NDA 202293 S-30) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval (supplemental) — 2023-09-12 FDA approved supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) — Labeling (NDA 209806 S-10) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2023-09-12 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Labeling (NDA 205649 S-21) Sponsor: ASTRAZENECA AB. Class: Labeling.FDA approval — 2023-10-05 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 217631) Sponsor: LAURUS.FDA approval (supplemental) — 2023-10-30 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-42) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2023-10-30 FDA approved supplemental application for Trijardy Xr (empagliflozin, linagliptin, metformin hydrochloride) — Labeling (NDA 212614 S-20) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2023-10-30 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-28) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval — 2023-11-03 FDA approved Sitagliptin And Metformin Hydrochloride (sitagliptin and metformin hydrochloride) (NDA 216743) Sponsor: ZYDUS LIFESCIENCES. Class: Type 5 - New Formulation or New Manufacturer.FDA approval (supplemental) — 2024-01-03 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 202917 S-6) Sponsor: SUN PHARM. Class: Labeling.FDA approval (supplemental) — 2024-01-03 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 202917 S-1) Sponsor: SUN PHARM. Class: Labeling.FDA approval (supplemental) — 2024-01-05 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 217631 S-1) Sponsor: LAURUS. Class: Labeling.FDA approval (supplemental) — 2024-01-19 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Labeling (NDA 205879 S-20) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2024-01-19 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-43) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval — 2024-03-13 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 211163) Sponsor: MACLEODS PHARMS LTD.FDA approval (supplemental) — 2024-03-29 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 077095 S-32) Sponsor: AUROBINDO. Class: Manufacturing (CMC).FDA approval (supplemental) — 2024-04-15 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 079118 S-16) Sponsor: AUROBINDO PHARMA LTD. Class: Manufacturing (CMC).FDA approval (supplemental) — 2024-06-04 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 075973 S-36) Sponsor: MYLAN. Class: Manufacturing (CMC).FDA approval (supplemental) — 2024-06-12 FDA approved supplemental application for Farxiga (dapagliflozin) — Efficacy (NDA 202293 S-31) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2024-06-12 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Efficacy (NDA 205649 S-22) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2024-06-28 FDA approved supplemental application for Actoplus Met (pioglitazone and metformin hydrochloride) — Labeling (NDA 021842 S-25) Sponsor: TAKEDA PHARMS USA. Class: Labeling.FDA approval — 2024-07-18 FDA approved Zituvimet Xr (sitagliptin and metformin hydrochloride) (NDA 216778) Sponsor: ZYDUS LIFESCIENCES. Class: Type 5 - New Formulation or New Manufacturer.FDA approval (supplemental) — 2024-08-23 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Labeling (NDA 205879 S-22) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2024-08-23 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Labeling (NDA 204353 S-45) Sponsor: JANSSEN PHARMS. Class: Labeling.FDA approval (supplemental) — 2024-09-27 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 202917 S-14) Sponsor: SUN PHARM. Class: Labeling.FDA approval — 2024-10-18 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 209694) Sponsor: AUROBINDO PHARMA.FDA approval (supplemental) — 2024-12-11 FDA approved supplemental application for Metformin Hydrochloride Oral Solution (metformin hydrochloride) — Labeling (ANDA 211309 S-9) Sponsor: SAPTALIS PHARMS. Class: Labeling.FDA approval (supplemental) — 2024-12-18 FDA approved supplemental application for Invokamet Xr (canagliflozin and metformin hydrochloride) — Efficacy (NDA 205879 S-23) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2024-12-18 FDA approved supplemental application for Invokamet (canagliflozin and metformin hydrochloride) — Efficacy (NDA 204353 S-46) Sponsor: JANSSEN PHARMS. Class: Efficacy.FDA approval (supplemental) — 2024-12-20 FDA approved supplemental application for Segluromet (ertugliflozin and metformin hydrochloride) — Labeling (NDA 209806 S-11) Sponsor: MSD SUB MERCK. Class: Labeling.FDA approval (supplemental) — 2024-12-20 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Efficacy (NDA 205649 S-23) Sponsor: ASTRAZENECA AB. Class: Efficacy.FDA approval (supplemental) — 2025-03-07 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Efficacy (NDA 206111 S-45) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval (supplemental) — 2025-03-07 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Efficacy (NDA 208658 S-32) Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.FDA approval — 2025-03-13 FDA approved Metformin Hydrochloride (metformin hydrochloride) (ANDA 215008) Sponsor: ANNORA PHARMA.FDA approval (supplemental) — 2025-03-24 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Labeling (ANDA 213344 S-1) Sponsor: GRANULES. Class: Labeling.FDA approval — 2025-04-14 FDA approved Metformin Hydrochloride Oral Solution (metformin hydrochloride) (ANDA 219151) Sponsor: BIONPHARMA.FDA approval (supplemental) — 2025-05-13 FDA approved supplemental application for Pioglitazone And Metformin Hydrochloride (pioglitazone and metformin hydrochloride) — Labeling (ANDA 204802 S-27) Sponsor: MACLEODS PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2025-05-13 FDA approved supplemental application for Pioglitazone And Metformin Hydrochloride (pioglitazone and metformin hydrochloride) — Labeling (ANDA 204802 S-36) Sponsor: MACLEODS PHARMS LTD. Class: Labeling.FDA approval (supplemental) — 2025-05-29 FDA approved supplemental application for Sitagliptin And Metformin Hydrochloride (sitagliptin and metformin hydrochloride) — Manufacturing (CMC) (NDA 216743 S-5) Sponsor: ZYDUS LIFESCIENCES. Class: Manufacturing (CMC).FDA approval (supplemental) — 2025-06-20 FDA approved supplemental application for Glyburide-Metformin Hydrochloride (glyburide-metformin hydrochloride) — Labeling (ANDA 079009 S-5) Sponsor: HERITAGE. Class: Labeling.FDA approval (supplemental) — 2025-06-20 FDA approved supplemental application for Glyburide-Metformin Hydrochloride (glyburide-metformin hydrochloride) — Labeling (ANDA 079009 S-11) Sponsor: HERITAGE. Class: Labeling.FDA approval (supplemental) — 2025-10-24 FDA approved supplemental application for Trijardy Xr (empagliflozin, linagliptin, metformin hydrochloride) — Labeling (NDA 212614 S-29) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2025-10-24 FDA approved supplemental application for Synjardy Xr (empagliflozin, metformin hydrochloride) — Labeling (NDA 208658 S-34) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval (supplemental) — 2025-10-24 FDA approved supplemental application for Synjardy (empagliflozin and metformin hydrochloride) — Labeling (NDA 206111 S-46) Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.FDA approval — 2025-11-03 FDA approved Linagliptin And Metformin Hydrochloride (linagliptin and metformin hydrochloride) (ANDA 208459) Sponsor: MSN.FDA approval (supplemental) — 2025-11-10 FDA approved supplemental application for Metformin Hydrochloride (metformin hydrochloride) — Manufacturing (CMC) (ANDA 090564 S-32) Sponsor: GRANULES INDIA. Class: Manufacturing (CMC).FDA approval — 2025-12-02 FDA approved Sitagliptin And Metformin Hydrochloride (sitagliptin and metformin hydrochloride) (ANDA 202388) Sponsor: SANDOZ.FDA approval — 2026-04-06 FDA approved Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) (ANDA 211563) Sponsor: ALKEM LABS LTD.FDA approval — 2026-04-06 FDA approved Dapagliflozin And Saxagliptin (dapagliflozin and saxagliptin) (ANDA 211533) Sponsor: MSN.FDA approval — 2026-04-06 FDA approved Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) (ANDA 211579) Sponsor: LUPIN.FDA approval — 2026-04-06 FDA approved Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) (ANDA 211491) Sponsor: SUN PHARM.FDA approval — 2026-04-06 FDA approved Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) (ANDA 211489) Sponsor: AUROBINDO PHARMA.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211541) Sponsor: TEVA PHARMS USA.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211545) Sponsor: ALKEM LABS LTD.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211560) Sponsor: ALEMBIC.FDA approval — 2026-04-06 FDA approved Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) (ANDA 211479) Sponsor: MSN.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211482) Sponsor: AJANTA PHARMA LTD.FDA approval — 2026-04-06 FDA approved Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) (ANDA 211559) Sponsor: MACLEODS PHARMS LTD.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211582) Sponsor: ZYDUS PHARMS.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211312) Sponsor: SANDOZ.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211468) Sponsor: AUROBINDO PHARMA.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211523) Sponsor: AIZANT.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211470) Sponsor: BIOCON PHARMA.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211156) Sponsor: INVENTIA.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211531) Sponsor: LUPIN.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211506) Sponsor: MACLEODS PHARMS LTD.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211535) Sponsor: CIPLA.FDA approval — 2026-04-06 FDA approved Dapagliflozin (dapagliflozin) (ANDA 211478) Sponsor: MSN.FDA approval (supplemental) — 2026-05-21 FDA approved supplemental application for Dapagliflozin And Metformin Hydrochloride (dapagliflozin and metformin hydrochloride) — Manufacturing (CMC) (ANDA 211491 S-1) Sponsor: SUN PHARM. Class: Manufacturing (CMC).Label revision — 2018-12-06 Boxed warning present on label on Riomet label (effective 2018-12-06) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin ‑ associated lactic acidosis is often subtle, accoLabel revision — 2020-12-31 Boxed warning present on label on Glipizide and Metformin Hydrochloride label (effective 2020-12-31) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2021-06-28 Boxed warning present on label on Metformin Hydrochloride label (effective 2021-06-28) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2021-12-08 Indication and usage updated on METFORMIN HYDROCHLORIDE EXTENDED RELEASE label (effective 2021-12-08) Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Label revision — 2022-03-21 Boxed warning present on label on Metformin Hydrochloride label (effective 2022-03-21) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2022-05-31 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2022-05-31) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2023-06-30 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2023-06-30) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2023-09-22 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2023-09-22) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2023-12-12 Indication and usage updated on FARXIGA label (effective 2023-12-12) 1 INDICATIONS AND USAGE FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risLabel revision — 2024-02-16 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2024-02-16) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accomLabel revision — 2024-04-05 Boxed warning present on label on Metformin Hydrochloride label (effective 2024-04-05) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often Label revision — 2024-08-05 Boxed warning present on label on Metformin Hydrochloride label (effective 2024-08-05) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is oftenLabel revision — 2024-08-21 Boxed warning present on label on Metformin Hydrochloride label (effective 2024-08-21) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is oftenLabel revision — 2024-09-26 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2024-09-26) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accomLabel revision — 2025-01-15 Boxed warning present on label on Metformin Hydrochloride label (effective 2025-01-15) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2025-02-03 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2025-02-03) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accomLabel revision — 2025-02-03 Indication and usage updated on Metformin HCl label (effective 2025-02-03) INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.Label revision — 2025-02-03 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2025-02-03) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accomLabel revision — 2025-03-26 Boxed warning present on label on METFORMIN HYDROCHLORIDE EXTENDED RELEASE label (effective 2025-03-26) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often Label revision — 2025-04-11 Boxed warning present on label on alogliptin and metformin hydrochloride label (effective 2025-04-11) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2025-04-23 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2025-04-23) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2025-06-09 Boxed warning present on label on ZITUVIMET label (effective 2025-06-09) WARNING: LACTIC ACIDOSIS WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning . Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradLabel revision — 2025-06-18 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2025-06-18) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompLabel revision — 2025-06-30 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2025-06-30) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2025-08-06 Boxed warning present on label on Metformin Hydrochloride label (effective 2025-08-06) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin- associated lactic acidosis is oftenLabel revision — 2025-08-06 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2025-08-06) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin ‑ associated lactic acidosis is often subtle, accoLabel revision — 2025-08-18 Boxed warning present on label on Metformin Hydrochloride label (effective 2025-08-18) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin- associated lactic acidosis is often subtle, accomLabel revision — 2025-08-22 Indication and usage updated on Metformin label (effective 2025-08-22) INDICATIONS & USAGE Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.Label revision — 2025-10-14 Boxed warning present on label on Glipizide and Metformin Hydrochloride label (effective 2025-10-14) Lactic Acidosis Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied onlLabel revision — 2025-10-15 Boxed warning present on label on Metformin Hydrochloride label (effective 2025-10-15) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2025-10-28 Boxed warning present on label on Metformin Hydrochloride label (effective 2025-10-28) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2025-10-31 Indication and usage updated on DAPAGLIFLOZIN label (effective 2025-10-31) 1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factoLabel revision — 2025-12-01 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2025-12-01) WARNING: LACTIC ACIDOSIS WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyaLabel revision — 2025-12-05 Indication and usage updated on Metformin HCl label (effective 2025-12-05) INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.Label revision — 2025-12-18 Boxed warning present on label on Metformin Hydrochloride label (effective 2025-12-18) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin- associated lactic acidosis is often subtle, accomLabel revision — 2025-12-26 Indication and usage updated on Metformin HCl label (effective 2025-12-26) INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.Label revision — 2026-01-01 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2026-01-01) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompLabel revision — 2026-01-01 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-01-01) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-01-14 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-01-14) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-01-28 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-01-28) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-01-29 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-01-29) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-01-30 Boxed warning present on label on Synjardy label (effective 2026-01-30) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-01-31 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2026-01-31) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-02-10 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-02-10) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-03-18 Boxed warning present on label on Metformin hydrochloride label (effective 2026-03-18) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accomLabel revision — 2026-04-02 Indication and usage updated on Dapagliflozin label (effective 2026-04-02) 1 INDICATIONS AND USAGE Dapagliflozin is indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. As anLabel revision — 2026-04-06 Indication and usage updated on Dapagliflozin label (effective 2026-04-06) 1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factoLabel revision — 2026-04-08 Indication and usage updated on Dapagliflozin label (effective 2026-04-08) 1 INDICATIONS AND USAGE Dapagliflozin tablet is indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factorsLabel revision — 2026-04-16 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-04-16) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-05 Boxed warning present on label on Metformin hydrochloride label (effective 2026-05-05) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin- associated lactic acidosis is often subtle, accomLabel revision — 2026-05-06 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-06) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is oftenLabel revision — 2026-05-07 Boxed warning present on label on Glyburide and Metformin Hydrochloride label (effective 2026-05-07) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompaLabel revision — 2026-05-07 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-07) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-07 Boxed warning present on label on Glyburide and Metformin Hydrochloride label (effective 2026-05-07) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompaLabel revision — 2026-05-08 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-08) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-11 Indication and usage updated on Dapagliflozin label (effective 2026-05-11) 1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factoLabel revision — 2026-05-11 Boxed warning present on label on Metformin hydrochloride label (effective 2026-05-11) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accomLabel revision — 2026-05-13 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-13) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-13 Indication and usage updated on Dapagliflozin label (effective 2026-05-13) 1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factoLabel revision — 2026-05-13 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-13) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-18 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-18) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-18 Indication and usage updated on Dapagliflozin label (effective 2026-05-18) 1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factoLabel revision — 2026-05-18 Indication and usage updated on Dapagliflozin label (effective 2026-05-18) 1 INDICATIONS AND USAGE Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factoLabel revision — 2026-05-19 Boxed warning revised on Metformin Hydrochloride label (effective 2026-05-19) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-21 Boxed warning present on label on glyburide and metformin hydrochloride label (effective 2026-05-21) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompaLabel revision — 2026-05-21 Boxed warning present on label on glyburide and metformin hydrochloride label (effective 2026-05-21) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompaLabel revision — 2026-05-21 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-21) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-21 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-21) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-22 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2026-05-22) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompLabel revision — 2026-05-22 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-05-22) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-05-22 Boxed warning present on label on METFORMIN HYDROCHLORIDE EXTENDED RELEASE label (effective 2026-05-22) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often Label revision — 2026-05-27 Indication and usage updated on Dapagliflozin label (effective 2026-05-27) 1 INDICATIONS AND USAGE Dapagliflozin tablet is indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factorsLabel revision — 2026-05-27 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2026-05-27) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-06-08 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2026-06-08) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompLabel revision — 2026-06-09 Boxed warning present on label on METFORMIN HYDROCHLORIDE ER label (effective 2026-06-09) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompLabel revision — 2026-06-09 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-06-09) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often Label revision — 2026-06-09 Boxed warning revised on METFORMIN HYDROCHLORIDE label (effective 2026-06-09) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompLabel revision — 2026-06-10 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-06-10) WARNING: LACTIC ACIDOSIS Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accomLabel revision — 2026-06-10 Boxed warning revised on glyburide and metformin hydrochloride label (effective 2026-06-10) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompaLabel revision — 2026-06-10 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2026-06-10) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin- associated lactic acidosis is often subtle, accomLabel revision — 2026-06-10 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-06-10) BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is oftenLabel revision — 2026-06-10 Boxed warning revised on glyburide and metformin hydrochloride label (effective 2026-06-10) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompaLabel revision — 2026-06-11 Indication and usage updated on Glipizide and Metformin Hydrochloride label (effective 2026-06-11) INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Label revision — 2026-06-11 Boxed warning present on label on Dapagliflozin and Metformin Hydrochloride label (effective 2026-06-11) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-06-11 Boxed warning revised on Metformin Hydrochloride label (effective 2026-06-11) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-06-11 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-06-11) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin- associated lactic acidosis is often subtle, accomLabel revision — 2026-06-12 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-06-12) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-06-12 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2026-06-12) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-06-12 Boxed warning present on label on METFORMIN HYDROCHLORIDE label (effective 2026-06-12) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-06-12 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-06-12) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompLabel revision — 2026-06-15 Boxed warning present on label on Metformin Hydrochloride label (effective 2026-06-15) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompRecall — 2014-01-28 METFORMIN HYDROCHLORIDE recall — Class II: Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NRecall — 2015-03-25 GLIPIZIDE AND METFORMIN HCL recall — Class II: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.Recall — 2016-10-19 INVOKAMET recall — Class III: Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NRecall — 2016-11-02 METFORMIN HYDROCHLORIDE recall — Class II: Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochlorid Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10Recall — 2017-04-18 RIOMET recall — Class II: Microbial Contamination of Non-Sterile Products Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, DistRecall — 2018-02-02 METFORMIN HYDROCHLORIDE recall — Class III: Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509Recall — 2018-04-26 RIOMET recall — Class III: Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling di Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02Recall — 2018-07-03 METFORMIN HYDROCHLORIDE recall — Class II: Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) cont Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-BarodaRecall — 2018-09-04 SYNJARDY recall — Class II: Cross Contamination With Other Products: Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, IRecall — 2020-01-24 PIOGLITAZONE AND METFORMIN HYDROCHLORIDE recall — Class III: Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydro Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDRecall — 2020-05-29 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDCRecall — 2020-05-29 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Recall — 2020-05-29 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Recall — 2020-05-29 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NRecall — 2020-06-05 METFORMIN HYDROCHLORIDE EXTENDED RELEASE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals IncRecall — 2020-06-05 METFORMIN HYDROCHLORIDE EXTENDED RELEASE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, Recall — 2020-06-11 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)Recall — 2020-07-03 METFORMIN recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India LimitedRecall — 2020-07-07 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09Recall — 2020-07-07 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07Recall — 2020-07-07 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01Recall — 2020-07-07 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07Recall — 2020-08-19 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-129-01Recall — 2020-08-19 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh NDC 76385-128-10Recall — 2020-10-02 METFORMIN HYDROCHLORIDE EXTENDED RELEASE recall — Class II: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured Recall — 2020-10-02 METFORMIN HYDROCHLORIDE EXTENDED RELEASE recall — Class II: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-Recall — 2020-10-06 METFORMIN HYDROCHLORIDE EXTENDED RELEASE recall — Class II: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60Recall — 2020-10-06 METFORMIN HYDROCHLORIDE EXTENDED RELEASE recall — Class II: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 7312Recall — 2020-10-12 METFORMIN HYDROCHLORIDE EXTENDED RELEASE recall — Class II: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90Recall — 2021-03-15 SYNJARDY recall — Class II: CGMP Deviations: Intermittent exposure to temperature excursion during storage. Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USARecall — 2021-03-15 JENTADUETO XR recall — Class II: CGMP Deviations: Intermittent exposure to temperature excursion during storage. Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USARecall — 2021-03-15 XIGDUO recall — Class II: CGMP Deviations: Intermittent exposure to temperature excursion during storage. xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing ComRecall — 2021-03-15 XIGDUO recall — Class II: CGMP Deviations: Intermittent exposure to temperature excursion during storage. xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850Recall — 2021-03-15 SYNJARDY recall — Class II: CGMP Deviations: Intermittent exposure to temperature excursion during storage. Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USARecall — 2021-03-25 METFORMIN HYDROCHLORIDE recall — Class III: Failed Moisture Limits: Out of specification for water content Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, HalRecall — 2021-03-31 RIOMET recall — Class II: Microbial Contamination of Non-Sterile Product Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631Recall — 2021-05-04 METFORMIN HYDROCHLORIDE recall — Class II: Presence of foreign substance: identified as activated carbon. Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Recall — 2021-06-01 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01Recall — 2021-12-27 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01Recall — 2022-03-31 JANUMET recall — Class II: Presence of foreign substance: Presence of stainless steel particulates in tablets. Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse StatioRecall — 2024-12-30 METFORMIN ER 500 MG recall — Class II: Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER T Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand CaymaRecall — 2025-02-25 METFORMIN HYDROCHLORIDE recall — Class II: Presence of Foreign Tablets/Capsules. METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.Recall — 2025-03-13 METFORMIN HYDROCHLORIDE recall — Class II: CGMP Deviations Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDCResults posted — 2010-02-01 Trial results posted: NCT00929201 Sitagliptin/Metformin Fed Bioequivalence Study (0431A-080)Results posted — 2010-03-15 Trial results posted: NCT00482729 MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)Results posted — 2010-10-18 Trial results posted: NCT00532935 MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)Results posted — 2011-04-14 Trial results posted: NCT00541450 A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 DResults posted — 2011-11-03 Trial results posted: NCT00830076 A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)Results posted — 2011-12-19 Trial results posted: NCT00986401 Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy SubjectsResults posted — 2012-07-13 Trial results posted: NCT00984490 Metformin Hydrochloride in Treating Women With Stage I or Stage II Breast Cancer That Can Be Removed By SurgeryResults posted — 2013-08-23 Trial results posted: NCT00660907 Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes PatientsResults posted — 2013-08-23 Trial results posted: NCT00673231 Efficacy and Safety of Dapagliflozin, Added to Therapy of Patients With Type 2 Diabetes With Inadequate Glycemic Control on InsulinResults posted — 2013-08-23 Trial results posted: NCT01042977 Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular DiseaseResults posted — 2013-08-23 Trial results posted: NCT01031680 Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and HypertensionResults posted — 2013-08-23 Trial results posted: NCT01294423 Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes MellitusResults posted — 2013-09-16 Trial results posted: NCT01294436 Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes MellitusResults posted — 2013-10-14 Trial results posted: NCT00855166 Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 DiabetesResults posted — 2013-10-14 Trial results posted: NCT00972244 Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus PatientsResults posted — 2013-10-14 Trial results posted: NCT00984867 Dapagliflozin DPPIV Inhibitor add-on StudyResults posted — 2013-10-14 Trial results posted: NCT00680745 Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes PatientsResults posted — 2013-11-01 Trial results posted: NCT01217892 Evaluation of Dapagliflozin Taken Twice-dailyResults posted — 2013-12-23 Trial results posted: NCT01662999 Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy ParticipantsResults posted — 2013-12-27 Trial results posted: NCT01392677 Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background CombResults posted — 2014-02-27 Trial results posted: NCT01589445 Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor GaResults posted — 2014-03-20 Trial results posted: NCT00859898 Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 DiabetesResults posted — 2014-05-01 Trial results posted: NCT01137474 A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-ConvertingResults posted — 2014-05-02 Trial results posted: NCT00528879 A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin AloneResults posted — 2014-05-02 Trial results posted: NCT00736879 Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 DiabetesResults posted — 2014-05-14 Trial results posted: NCT00528372 A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and ExerciseResults posted — 2014-05-23 Trial results posted: NCT01195662 A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an AdResults posted — 2014-07-21 Trial results posted: NCT01447927 Metformin Hydrochloride in Preventing Esophageal Cancer in Patients With Barrett EsophagusResults posted — 2015-05-15 Trial results posted: NCT01433913 Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing SurgeryResults posted — 2015-06-25 Trial results posted: NCT01312467 Trial of Metformin for Colorectal Cancer Risk Reduction for History of Colorectal Adenomas and Elevated BMIResults posted — 2015-10-20 Trial results posted: NCT01606007 Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 DiabetesResults posted — 2016-03-17 Trial results posted: NCT02157298 Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of JapResults posted — 2016-03-17 Trial results posted: NCT01619059 Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 DiabetesResults posted — 2016-04-11 Trial results posted: NCT01646320 Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 DiabetesResults posted — 2016-04-27 Trial results posted: NCT02223065 Bioequivalence Study Coadministered to Healthy Subjects in the Fasted StateResults posted — 2016-06-06 Trial results posted: NCT02068443 Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 DiabResults posted — 2016-11-21 Trial results posted: NCT01525238 PK Study of Dapagliflozin in Pediatric Subjects With T2DMResults posted — 2016-11-22 Trial results posted: NCT02024971 Special Drug Use Surveillance of Pioglitazone/Metformin Hydrochloride Combination Tablets Survey on Long-term Use for Type 2 Diabetes MellitResults posted — 2017-01-27 Trial results posted: NCT02279407 A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic PatientsResults posted — 2017-02-06 Trial results posted: NCT01095653 A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and ExerciseResults posted — 2017-02-10 Trial results posted: NCT01498185 BMS - Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Dapagliflozin in Type 1 DiabetesResults posted — 2017-02-10 Trial results posted: NCT00663260 Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal ImpairmentResults posted — 2017-02-23 Trial results posted: NCT00683878 Add-on to Thiazolidinedione (TZD) FailuresResults posted — 2017-02-23 Trial results posted: NCT00643851 An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release TabletsResults posted — 2017-03-01 Trial results posted: NCT00831779 Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 DiabetesResults posted — 2017-03-06 Trial results posted: NCT02096705 Phase III Insulin Add-On Asia Regional Program - STResults posted — 2017-03-08 Trial results posted: NCT00976495 Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 DiabetesResults posted — 2017-04-11 Trial results posted: NCT02429258 Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or InsulinResults posted — 2017-05-11 Trial results posted: NCT00357370 A Pilot Study of BMS-512148 in Subjects With Type 2 DiabetesResults posted — 2017-09-08 Trial results posted: NCT02229396 Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin VResults posted — 2017-09-11 Trial results posted: NCT01095666 A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin AloneResults posted — 2017-10-16 Trial results posted: NCT01561976 Evaluation of Food Effect on the Pharmacokinetics of Sustained Release Metformin in Healthy Indian VolunteersResults posted — 2018-02-05 Trial results posted: NCT02426541 Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes MellitusResults posted — 2018-02-19 Trial results posted: NCT02722239 An Open-label, Randomized, Crossover Study of Comparative Pharmacokinetics and Bioequivalence of Dapagliflozin + Metformin, 10 mg + 1000 mg Results posted — 2018-03-13 Trial results posted: NCT02637037 A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy SubjectsResults posted — 2018-03-29 Trial results posted: NCT02268214 Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 DiabetesResults posted — 2018-06-01 Trial results posted: NCT02284893 Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to SitaglResults posted — 2018-08-06 Trial results posted: NCT02854527 Transporter Cocktail Mutual InteractionResults posted — 2018-09-18 Trial results posted: NCT02551874 A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With DapaglResults posted — 2018-10-10 Trial results posted: NCT02532855 A Study to Assess the Addition of Sitagliptin to Metformin Compared With the Addition of Dapagliflozin to Metformin in Participants With TypResults posted — 2018-10-10 Trial results posted: NCT02681094 A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With DapaglifloResults posted — 2018-10-19 Trial results posted: NCT02419612 A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With MetforResults posted — 2018-10-31 Trial results posted: NCT02413398 A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 DiabetesResults posted — 2018-11-06 Trial results posted: NCT02460978 Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 DiabetesResults posted — 2018-11-13 Trial results posted: NCT01849276 Metformin+Cytarabine for the Treatment of Relapsed/Refractory AMLResults posted — 2018-12-11 Trial results posted: NCT02520518 Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?Results posted — 2019-01-18 Trial results posted: NCT02582840 The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DMResults posted — 2019-03-26 Trial results posted: NCT02471404 Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared WResults posted — 2019-04-10 Trial results posted: NCT02371187 Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?Results posted — 2019-04-12 Trial results posted: NCT02582814 The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DMResults posted — 2019-05-02 Trial results posted: NCT02475070 Vildagliptin Versus Dapagliflozin on GlucagonResults posted — 2019-05-23 Trial results posted: NCT02581137 Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant LesionResults posted — 2019-06-04 Trial results posted: NCT02547935 A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin Results posted — 2019-07-18 Trial results posted: NCT03316131 A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UResults posted — 2019-08-14 Trial results posted: NCT02613897 ESR-15-11293 - Saxa/Dapa, Safety and Efficacy StudyResults posted — 2019-08-20 Trial results posted: NCT02564926 Foxiga Korea Local Phase 4 StudyResults posted — 2019-10-29 Trial results posted: NCT01439854 Study of Dapagliflozin on Mitochondrial Dysfunction and Impaired Insulin Signaling/ActionResults posted — 2019-10-30 Trial results posted: NCT02433678 An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of DapagliflozinResults posted — 2019-11-20 Trial results posted: NCT03109873 Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck CancerResults posted — 2019-12-18 Trial results posted: NCT02592421 SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2Results posted — 2019-12-18 Trial results posted: NCT02984644 Paradoxical Stimulation of Hepatic Glucose Production With DapagliflozinResults posted — 2019-12-26 Trial results posted: NCT01730534 Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular EventsResults posted — 2020-01-14 Trial results posted: NCT03168295 PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to GlucosuriaResults posted — 2020-02-11 Trial results posted: NCT03180489 Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?Results posted — 2020-03-25 Trial results posted: NCT03387683 A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 DiaResults posted — 2020-04-08 Trial results posted: NCT02608905 Effect of Dapagliflozin on Inflammation and Endothelial FunctionResults posted — 2020-07-07 Trial results posted: NCT02682563 Renoprotective Effects of Dapagliflozin in Type 2 DiabetesResults posted — 2020-08-04 Trial results posted: NCT03074630 Dapagliflozin and Cholesterol Metabolism in Type 2 Diabetes (DM2)Results posted — 2020-09-01 Trial results posted: NCT03036124 Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic HResults posted — 2020-10-08 Trial results posted: NCT02113241 Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin SecretionResults posted — 2020-10-08 Trial results posted: NCT02700334 Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With PrediabetesResults posted — 2020-10-14 Trial results posted: NCT03048500 Nivolumab and Metformin Hydrochloride in Treating Patients With Stage III-IV Non-small Cell Lung Cancer That Cannot Be Removed by SurgeryResults posted — 2020-10-19 Trial results posted: NCT03006471 Effect of Dapagliflozin on Blood Pressure Variability in Prediabetes and PrehypertensionResults posted — 2020-10-22 Trial results posted: NCT02973477 Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)Results posted — 2020-11-23 Trial results posted: NCT03555565 Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes MellitusResults posted — 2020-12-02 Trial results posted: NCT02725593 Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 YearsResults posted — 2021-01-12 Trial results posted: NCT02065687 Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial CancerResults posted — 2021-01-15 Trial results posted: NCT03338855 Effects of 5 Weeks Treatment With Dapagliflozin in Type 2 Diabetes Patients on How the Hormone Insulin Acts on Sugar Uptake in Muscles.Results posted — 2021-01-29 Trial results posted: NCT02635386 EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)Results posted — 2021-02-16 Trial results posted: NCT02235298 Dapagliflozin Effects on Epicardial FatResults posted — 2021-05-05 Trial results posted: NCT03877237 DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced EjectioResults posted — 2021-05-28 Trial results posted: NCT03152084 The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With PreservResults posted — 2021-07-07 Trial results posted: NCT03036150 A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney DiseaseResults posted — 2021-08-10 Trial results posted: NCT01666730 Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic CancerResults posted — 2021-11-17 Trial results posted: NCT03877224 DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved EjeResults posted — 2021-12-01 Trial results posted: NCT02653482 Dapagliflozin Effect on Symptoms and Biomarkers in Patients With Heart FailureResults posted — 2022-04-13 Trial results posted: NCT04350593 Dapagliflozin in Respiratory Failure in Patients With COVID-19Results posted — 2022-10-18 Trial results posted: NCT01101438 A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast CancerResults posted — 2022-10-18 Trial results posted: NCT02176161 Metformin Prostate Cancer Adjuvant TrialResults posted — 2022-10-19 Trial results posted: NCT03030235 Dapagliflozin in PRESERVED Ejection Fraction Heart FailureResults posted — 2022-11-01 Trial results posted: NCT02796170 Inhibition of Urinary Angiotensinogen and the Reduction of Blood Pressure by SGLT2 Inhibition in Patients With Type 2 DiabetesResults posted — 2023-01-11 Trial results posted: NCT03772964 Effects of Metformin in a Non-Diabetic Patient PopulationResults posted — 2023-01-17 Trial results posted: NCT04542291 Targeting Pancreatic Cancer With Sodium Glucose Transporter 2 (SGLT2) InhibitionResults posted — 2023-02-08 Trial results posted: NCT02420652 Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or RadiatiResults posted — 2023-03-29 Trial results posted: NCT04249778 Dapagliflozin at Discharge on Hospital Heart Failure ReadmissionResults posted — 2023-06-05 Trial results posted: NCT03660683 Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes MellitusResults posted — 2023-06-06 Trial results posted: NCT02981966 Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism SubjectsResults posted — 2023-07-11 Trial results posted: NCT03619213 Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.Results posted — 2023-07-20 Trial results posted: NCT02981069 Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in T2DMResults posted — 2023-07-24 Trial results posted: NCT03331289 Can Exenatide Prevent Increase in EGP in Response to Dapagliflozin-induced Increase in GlucosuriaResults posted — 2023-08-18 Trial results posted: NCT04288778 A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve BlooResults posted — 2023-10-12 Trial results posted: NCT04730947 Dapagliflozin (DAPA) Effects in HFpEFResults posted — 2023-11-30 Trial results posted: NCT02911792 Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With HyperfiltrationResults posted — 2023-12-12 Trial results posted: NCT04899349 Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer WhiResults posted — 2023-12-26 Trial results posted: NCT04492722 A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney DiseaseResults posted — 2023-12-29 Trial results posted: NCT03782259 Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2Results posted — 2024-01-05 Trial results posted: NCT04401904 SGLT2 Inhibition in Older Obese Adults With Pre-diabetesResults posted — 2024-01-24 Trial results posted: NCT02518945 Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 DiabetesResults posted — 2024-02-29 Trial results posted: NCT02777073 Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 DiabetesResults posted — 2024-02-29 Trial results posted: NCT02962492 An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 DiabetesResults posted — 2024-03-15 Trial results posted: NCT04298229 Efficacy and Safety of Dapagliflozin in Acute Heart FailureResults posted — 2024-04-17 Trial results posted: NCT03199053 Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Results posted — 2024-06-13 Trial results posted: NCT03801642 Dapagliflozin In Alzheimer's DiseaseResults posted — 2024-06-17 Trial results posted: NCT03190694 Effects of Dapagliflozin in Non-diabetic Patients With ProteinuriaResults posted — 2024-06-18 Trial results posted: NCT03733132 Metformin Effect on Brain Function in Insulin Resistant Elderly PeopleResults posted — 2024-07-03 Trial results posted: NCT03762850 A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA NephropathyResults posted — 2024-07-10 Trial results posted: NCT04170543 A Phase 2b Diabetic Kidney Disease StudyResults posted — 2024-07-18 Trial results posted: NCT03331861 Metformin in Heart Failure Without DiabetesResults posted — 2024-07-30 Trial results posted: NCT04724837 Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)Results posted — 2024-11-12 Trial results posted: NCT04445714 To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus PatientsResults posted — 2024-11-19 Trial results posted: NCT04595370 Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney DiseaseResults posted — 2024-12-04 Trial results posted: NCT04792190 Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial FibrillationResults posted — 2025-03-07 Trial results posted: NCT04564742 Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.Results posted — 2025-03-17 Trial results posted: NCT02980276 RCT Metformin for Reduction of Gestational Diabetes Mellitus EffectsResults posted — 2025-04-13 Trial results posted: NCT01905046 Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast CancerResults posted — 2025-04-16 Trial results posted: NCT05748925 Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis PatientsResults posted — 2025-10-08 Trial results posted: NCT04818034 The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary StudyResults posted — 2025-10-15 Trial results posted: NCT03968224 Effectiveness of Dapagliflozin for Weight LossResults posted — 2025-12-11 Trial results posted: NCT03109847 Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid CancersResults posted — 2026-01-09 Trial results posted: NCT06504862 A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and FuroResults posted — 2026-01-20 Trial results posted: NCT06269484 A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCKResults posted — 2026-01-28 Trial results posted: NCT06263673 Anti-Diabetic Medications to Fight PD and LBDResults posted — 2026-01-29 Trial results posted: NCT03076281 Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell CarcinomaResults posted — 2026-02-11 Trial results posted: NCT05139914 Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 DiabetesResults posted — 2026-03-27 Trial results posted: NCT02122185 Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal CancerResults posted — 2026-04-22 Trial results posted: NCT02874430 Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine CancerResults posted — 2026-06-08 Trial results posted: NCT04965935 Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant RecipientsResults posted — 2026-06-16 Trial results posted: NCT04363697 Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)Pivotal publication — 2020-01-01 SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. (Lancet) DACAMI — Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic PatientsPivotal publication — 2020-01-01 Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes. (JAMA) DAPA-HF — Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart FailurePivotal publication — 2020-01-01 Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. (N Engl J Med) DACAMI — Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic PatientsPivotal publication — 2021-01-01 New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race. (N Engl J Med) Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney DiseasePivotal publication — 2021-01-01 Chronic kidney disease. (Lancet) Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney DiseasePivotal publication — 2022-01-01 Acetazolamide in Acute Decompensated Heart Failure with Volume Overload. (N Engl J Med) Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure PatientsPivotal publication — 2024-01-01 Dapagliflozin for Critically Ill Patients With Acute Organ Dysfunction: The DEFENDER Randomized Clinical Trial. (JAMA) DEFENDER — Dapagliflozin in Patients With Critical IllnessPivotal publication — 2025-01-01 Effect of dapagliflozin on metabolic dysfunction-associated steatohepatitis: multicentre, double blind, randomised, placebo controlled trial. (BMJ) DEAN — Dapagliflozin Efficacy and Action in NASHtoday (2026-06-18)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-18Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Dapagliflozin since 2002, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (58)

2026

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients W
Primary completion· ClinicalTrials.gov
Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
Trial started· ClinicalTrials.gov
The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy
Primary completion· ClinicalTrials.gov
Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations
Primary completion· ClinicalTrials.gov
Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)
Primary completion· ClinicalTrials.gov
A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chroni
Primary completion· ClinicalTrials.gov
The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers
Trial started· ClinicalTrials.gov
DP-DCT 1.0:A Comparative Clinical Study on the Effect of Dapagliflozin Combined With CGM Versus SMBG on Glycemic Control in Patients With Ty
Primary completion· ClinicalTrials.gov
Danish Precocious Puberty Study - DAPP Study A National Cohort Study on Incidence and Etiologies for Precocious Puberty
Primary completion· ClinicalTrials.gov
Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI
Primary completion· ClinicalTrials.gov
Effect of Glp-1 and Antidiabetic sgLT2 Agents for myoCardial infarcTion and Ultrasensitive Inflammatory Surveillance (GALACTUS Trial)
Trial started· ClinicalTrials.gov
A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
Primary completion· ClinicalTrials.gov
Can the Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Pl
Primary completion· ClinicalTrials.gov
Effect of SGLT2 Inhibitors on NAFLD in Type 2 Diabetic Patients with Diabetic Nephropathy
Primary completion· ClinicalTrials.gov
Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Trial started· ClinicalTrials.gov
Dapagliflozin Versus Metformin for the Management of Antipsychotic-Induced Weight Gain: A Pragmatic Pilot Randomized Controlled Trial
Primary completion· ClinicalTrials.gov
Epicardial Adipose Tissue-Targeted DApagliflozin for Reducing Electrical Remodeling in Atrial Fibrillation
Primary completion· ClinicalTrials.gov
Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity
Primary completion· ClinicalTrials.gov
A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedion
Primary completion· ClinicalTrials.gov
Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
Primary completion· ClinicalTrials.gov
A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study

Past events

2026
Results posted· ClinicalTrials.gov
Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)
Primary completion· ClinicalTrials.gov
Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease
Trial started· ClinicalTrials.gov
Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prosta
Primary completion· ClinicalTrials.gov
IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency
Primary completion· ClinicalTrials.gov
Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation
Trial started· ClinicalTrials.gov
The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure
Trial started· ClinicalTrials.gov
Early Gliflozin for Elderly Patients With Acute Decompensated Heart Failure in the Emergency Department
Trial started· ClinicalTrials.gov
Comparative Effectiveness of Dapagliflozin, Metformin, and Lifestyle Modification for Antipsychotic-Induced Weight Gain: An Open-Label Pragm
Primary completion· ClinicalTrials.gov
Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prosthetic Heart Valves
Trial started· ClinicalTrials.gov
Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Adolescents With Early Stages of Chronic Kidney Disease
Results posted· ClinicalTrials.gov
Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
Primary completion· ClinicalTrials.gov
A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food
Primary completion· ClinicalTrials.gov
Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
Results posted· ClinicalTrials.gov
Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Trial started· ClinicalTrials.gov
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic So
Primary completion· ClinicalTrials.gov
Effects Dapagliflozin on Inflammatory Markers Erythropoiesis and Iron Metabolism in Patients With Type 2 Diabetes and CKD
Trial started· ClinicalTrials.gov
The Effect of Dapagliflozin on Myocardial Strain in Patients With Acute Heart Failure
Trial started· ClinicalTrials.gov
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Primary completion· ClinicalTrials.gov
A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metform
Trial started· ClinicalTrials.gov
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes in Non-diabetic ACS Patients Without HF
Primary completion· ClinicalTrials.gov
A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
Trial started· ClinicalTrials.gov
A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food
Trial started· ClinicalTrials.gov
A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
Trial started· ClinicalTrials.gov
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Mida
Primary completion· ClinicalTrials.gov
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
Primary completion· ClinicalTrials.gov
Impact of Dapagliflozin on Intestinal Microbiota Composition and on the Metabolites Derived From the Intestinal Microbiota in Non-diabetic C
Primary completion· ClinicalTrials.gov
Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy
Results posted· ClinicalTrials.gov
Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma
Results posted· ClinicalTrials.gov
A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK
Results posted· ClinicalTrials.gov
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furo
Trial started· ClinicalTrials.gov
A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metform
Trial started· ClinicalTrials.gov
Epicardial Adipose Tissue-Targeted DApagliflozin for Reducing Electrical Remodeling in Atrial Fibrillation
2025
Primary completion· ClinicalTrials.gov
Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes
Trial started· ClinicalTrials.gov
Effect of Glp-1 and Antidiabetic sgLT2 Agents for myoCardial infarcTion and Ultrasensitive Inflammatory Surveillance (GALACTUS Trial)
Primary completion· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in F
Primary completion· ClinicalTrials.gov
A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to Balcinrenone and Plac
Trial started· ClinicalTrials.gov
A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus a
Primary completion· ClinicalTrials.gov
A Pragmatic Randomized Trial to Evaluate the Comparative Effectiveness Between Dapagliflozin and Standard of Care in Type 2 Diabetes Patient
Trial started· ClinicalTrials.gov
A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Particip

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.