| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS and METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Laurus Labs Limited | Laurus Labs Limited (VSP2) | 2026-09-25 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | GLENMARK PHARMACEUTICALS INC., USA | Glenmark Pharmaceuticals Limited | 2026-09-23 |
| GLIPIZIDE AND METFORMIN HCl tablet, film coated A077270 | Product name | REMEDYREPACK INC. | 2026-09-22 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-09-21 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Leading Pharma, LLC | Inventia Healthcare Limited | 2026-09-21 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Ascend Laboratories, LLC | Inventia Healthcare Limited | 2026-09-21 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | A-S Medication Solutions | 2026-09-21 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014 | Product name | Sun Pharmaceutical Industries, Inc. | Ohm Laboratories Inc. | 2026-09-17 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | NuCare Pharmaceuticals, Inc. | 2026-09-17 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014 | Product name | Macleods Pharmaceuticals Limited | 2026-09-16 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, For oral use Initial U.S. Approval: 1995 | Product name | Macleods Pharmaceuticals Limited | 2026-09-16 |
| These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS PIOGLITAZONE and METFORMIN HYDROCHLORIDE tablets for oral use Initial U.S. Approval: 2005 | Product name | Macleods Pharmaceuticals Limited | 2026-09-16 |
| Metformin Hydrochloride Tablets USP | Product name | REMEDYREPACK INC. | 2026-09-11 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-09-09 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-09-09 |
| Metformin Hydrochloride Extended-Release Tablets 500 mg and 750 mg These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-09-09 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-09-08 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Ajanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | 2026-09-08 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE ORAL SOLUTION. METFORMIN HYDROCHLORIDE oral solution Initial U.S. Approval: 1995 | Product name | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 2026-09-08 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN hydrochloride extended-release tablets for oral use Initial U.S. Approval: 1995 | Product name | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2026-09-07 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Ajanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | 2026-09-04 |
| METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use. Initial U.S. Approval: 1995 | Product name | Granules India Ltd | 2026-09-03 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014 | Product name | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2026-09-02 |
| These highlights do not include all the information needed to use GLUMETZA safely and effectively. See full prescribing information for GLUMETZA. GLUMETZA ® (metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Santarus, Inc. | Patheon Puerto Rico, Inc. | Bausch Health Companies Inc. | 2026-09-02 |
| These highlights do not include all the information needed to use GLUMETZA safely and effectively. See full prescribing information for GLUMETZA. GLUMETZA ® (metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Santarus, Inc. | Patheon Puerto Rico, Inc. | Bausch Health Companies Inc. | 2026-09-02 |
| These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2005 | Product name | Aurobindo Pharma Limited | 2026-09-02 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-09-01 |
| These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE tablets , for oral use Initial U.S. Approval: 2005 | Product name | Torrent Pharmaceuticals Limited | Torrent Pharma, Inc. | 2026-09-01 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-08-28 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Bryant Ranch Prepack | 2026-08-26 |
| These highlights do not include all the information needed to use ALOGLIPTIN AND METFORMIN HCl TABLETS safely and effectively. See full prescribing information for ALOGLIPTIN AND METFORMIN HCl TABLETS. Alogliptin and Metformin Hydrochloride Tablets, for oral use Initial U.S. Approval: 2013 | Product name | Padagis Israel Pharmaceuticals Ltd | 2026-08-25 |
| These highlights do not include all the information needed to use SYNJARDY and SYNJARDY XR safely and effectively. See full prescribing information for SYNJARDY and SYNJARDY XR. SYNJARDY ® (empagliflozin and metformin hydrochloride tablets), for oral use SYNJARDY ® XR (empagliflozin and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 2015 | Product name | Boehringer Ingelheim Pharmaceuticals, Inc. | 2026-08-25 |
| These highlights do not include all the information needed to use INVOKAMET or INVOKAMET XR safely and effectively. See full prescribing information for INVOKAMET or INVOKAMET XR. INVOKAMET ® (canagliflozin and metformin hydrochloride) tablets, for oral use INVOKAMET ® XR (canagliflozin and metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014 | Product name | Janssen Pharmaceuticals, Inc. | Janssen Pharmaceuticals Inc | Patheon Puerto Rico, Inc. | PHAST Gesellschaft für Pharmazeutische Qualitätsstandards mbH | Janssen Pharmaceutica NV | Ajinomoto OmniChem | Farmhispania | Rolabo Outsourcing S.L. (Spain) | Janssen Cilag SpA | Johnson & Johnson Private Limited (Mumbai) | Janssen Ortho LLC | Granules India Limited | 2026-08-24 |
| These highlights do not include all the information needed to use TRIJARDY XR safely and effectively. See full prescribing information for TRIJARDY XR. TRIJARDY ® XR (empagliflozin, linagliptin, and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 2020 | Product name | Boehringer Ingelheim Pharmaceuticals, Inc. | 2026-08-24 |
| These highlights do not include all the information needed to use ACTOPLUS MET ® safely and effectively. See full prescribing information for ACTOPLUS MET. ACTOPLUS MET (pioglitazone and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2005 | Product name | Takeda Pharmaceuticals America, Inc. | Daito Pharmaceutical Co., Ltd | Farmhispania S.A. | Juzen Chemical Corporation | ZACH SYSTEM S.A. | AndersonBrecon Inc. | Pace Analytical Life Sciences, LLC | Takeda Ireland Ltd. | 2026-08-21 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-08-21 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | ScieGen Pharmaceuticals Inc | 2026-08-21 |
| These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2010 | Product name | Mylan Pharmaceuticals Inc. | 2026-08-21 |
| These highlights do not include all the information needed to use JENTADUETO safely and effectively. See full prescribing information for JENTADUETO. JENTADUETO ® (linagliptin and metformin hydrochloride tablets), for oral use Initial U.S. Approval: 2012 | Product name | Boehringer Ingelheim Pharmaceuticals, Inc. | Boehringer Ingelheim Pharma GmbH and Co. KG | Boehringer Ingelheim Promeco S.A. de C.V. | VISTIN Pharma AS | Sixarp, LLC | 2026-08-19 |
| These highlights do not include all the information needed to use JENTADUETO XR safely and effectively. See full prescribing information for JENTADUETO XR. JENTADUETO ® XR (linagliptin and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 2012 | Product name | Boehringer Ingelheim Pharmaceuticals, Inc. | 2026-08-19 |
| These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 | Product name | Bryant Ranch Prepack | 2026-08-18 |
| These highlights do not include all the information needed to use KAZANO ® safely and effectively. See full prescribing information for KAZANO. KAZANO (alogliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2013 | Product name | Takeda Pharmaceuticals America, Inc. | 2026-08-17 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Quallent Pharmaceuticals Health LLC | Zydus Lifesciences Limited | 2026-08-12 |
| These highlights do not include all the information needed to use SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS. SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007 | Product name | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited | 2026-08-12 |
| These highlights do not include all the information needed to use SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS. SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007 | Product name | Zydus Lifesciences Limited | 2026-08-12 |
| These highlights do not include all the information needed to use ZITUVIMET safely and effectively. See full prescribing information for ZITUVIMET. ZITUVIMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007 | Product name | Zydus Lifesciences Limited | 2026-08-12 |
| These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET. JANUMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007 | Product name | Merck Sharp & Dohme LLC | 2026-08-11 |
| These highlights do not include all the information needed to use JANUMET XR safely and effectively. See full prescribing information for JANUMET XR. JANUMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 2012 | Product name | Merck Sharp & Dohme LLC | 2026-08-11 |
| These highlights do not include all the information needed to use SEGLUROMET safely and effectively. See full prescribing information for SEGLUROMET. SEGLUROMET ® (ertugliflozin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2017 | Product name | Merck Sharp & Dohme LLC | 2026-08-11 |
| These highlights do not include all the information needed to use SYNJARDY and SYNJARDY XR safely and effectively. See full prescribing information for SYNJARDY and SYNJARDY XR. SYNJARDY ® (empagliflozin and metformin hydrochloride tablets), for oral use SYNJARDY ® XR (empagliflozin and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 2015 | Product name | Boehringer Ingelheim Pharmaceuticals, Inc. | 2026-08-11 |
| These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full prescribing information for XIGDUO XR. XIGDUO ® XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 2014 | Product name | AstraZeneca Pharmaceuticals LP | 2026-08-11 |
| These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full prescribing information for XIGDUO XR. XIGDUO ® XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 2014 | Product name | AstraZeneca Pharmaceuticals LP | 2026-08-11 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-08-04 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-08-04 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-08-04 |
| Metformin Hydrochloride Tablets USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-08-03 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-08-03 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-08-03 |
| Metformin Hydrochloride Tablets USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-31 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-31 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-30 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-30 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-29 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-07-29 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-07-28 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Cardinal Health 107, LLC | 2026-07-24 |
| METFORMIN HYDROCHLORIDE TABLETS These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval:1995 | Product name | Chartwell RX, LLC | 2026-07-20 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Granules India Ltd | 2026-07-17 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-07-16 |
| These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 | Product name | Bryant Ranch Prepack | 2026-07-15 |
| These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 | Product name | Bryant Ranch Prepack | 2026-07-15 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS . METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2026-07-15 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Aurobindo Pharma Limited | 2026-07-15 |
| These highlights do not include all the information needed to use ZITUVIMET safely and effectively. See full prescribing information for ZITUVIMET. ZITUVIMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007 | Product name | Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited | 2026-07-15 |
| Metformin Hydrochloride Tablets USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-13 |
| These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET. JANUMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007 | Product name | A-S Medication Solutions | 2026-07-13 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | REMEDYREPACK INC. | 2026-07-10 |
| These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET. JANUMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 2007 | Product name | A-S Medication Solutions | 2026-07-09 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2026-07-08 |
| These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2010 | Product name | Dr.Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT) | 2026-07-08 |
| These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 | Product name | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | USV Private Limited | 2026-07-07 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-07 |
| These highlights do not include all the information needed to use Metformin Hydrochloride Extended-release Tablets safely and effectively.See full prescribing information for Metformin Hydrochloride Extended-release Tablets. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-07-07 |
| These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 | Product name | Rising Pharma Holdings, Inc. | Aurobindo Pharma Limited | 2026-07-03 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Amneal Pharmaceuticals LLC | 2026-07-01 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS Initial U.S. Approval: 1995 | Product name | Unichem Pharmaceuticals (USA), Inc. | Unichem Laboratories Limited, India | Unichem Laboratories Limited | 2026-07-01 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Leading Pharma, LLC | Inventia Healthcare Limited | 2026-07-01 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Leading Pharma, LLC | Inventia Healthcare Limited | 2026-07-01 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Ascend Laboratories, LLC | Inventia Healthcare Limited | 2026-07-01 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Ascend Laboratories, LLC | Inventia Healthcare Limited | 2026-07-01 |
| These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 | Product name | Aurobindo Pharma Limited | 2026-06-30 |
| These highlights do not include all the information needed to use GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLETS. GLYBURIDE and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2000 | Product name | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | USV Private Limited | 2026-06-30 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Granules India Ltd | 2026-06-30 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE ORAL SOLUTION . METFORMIN HYDROCHLORIDE oral solution Initial U.S. Approval: 1995 | Product name | VistaPharm, LLC | 2026-06-30 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | MARKSANS PHARMA LIMITED | 2026-06-29 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Granules India Ltd | GRANULES LIFE SCIENCES PRIVATE LIMITED | 2026-06-29 |
| Glipizide and Metformin Hydrochloride Tablets, USP | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2026-06-27 |
| Glipizide and Metformin Hydrochloride Tablets USP 2.5 mg/250 mg 2.5 mg/500 mg 5 mg/500 mg Rx Only | Product name | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | USV Private Limited | 2026-06-26 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Marlex Pharmaceuticals, Inc. | 2026-06-26 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Viona Pharmaceuticals Inc | Zydus Lifesciences Limited | 2026-06-26 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2026-06-25 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | AiPing Pharmaceutical, Inc. | Qingdao BAHEAL Pharmaceutical Co., Ltd. | 2026-06-25 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Major Pharmaceuticals | 2026-06-24 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Preferred Pharmaceuticals Inc. | 2026-06-22 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Preferred Pharmaceuticals Inc. | 2026-06-19 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Preferred Pharmaceuticals Inc. | 2026-06-19 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Preferred Pharmaceuticals Inc. | 2026-06-19 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | Preferred Pharmaceuticals Inc. | 2026-06-19 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN hydrochloride extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Preferred Pharmaceuticals, Inc. | 2026-06-18 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS Initial U.S. Approval: 1995 | Product name | Unichem Pharmaceuticals (USA), Inc. | Unichem Laboratories Limited, India | Unichem Laboratories Limited | 2026-06-18 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Bryant Ranch Prepack | 2026-06-16 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Mylan Pharmaceuticals Inc. | 2026-06-15 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | A-S Medication Solutions | 2026-06-12 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | A-S Medication Solutions | 2026-06-12 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | A-S Medication Solutions | 2026-06-12 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE TABLETS. METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1995 | Product name | A-S Medication Solutions | 2026-06-12 |
| GLIPIZIDE AND METFORMIN HCl tablet, film coated A077270 | Product name | Teva Pharmaceuticals USA, Inc. | 2026-06-11 |
| Glipizide and Metformin Hydrochloride Tablets, USP | Product name | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2026-06-11 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Bryant Ranch Prepack | 2026-06-11 |
| These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Product name | Viona Pharmaceuticals Inc | Zydus Lifesciences Limited | 2026-06-11 |