| DAPAGLIFLOZIN tablets, for oral use These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. Initial U.S. Approval: 2014 | AvKARE | 20260527 | 2 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | A-S Medication Solutions | 20260518 | 1 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | A-S Medication Solutions | 20260518 | 1 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | ANI Pharmaceuticals, Inc. | 20260513 | 1 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260511 | 2 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Florida Pharmaceutical Products, LLC | Inventia Healthcare Limited. | Inventia Healthcare Limited | 20260428 | 3 |
| These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014 | REMEDYREPACK INC. | 20260424 | 1 |
| 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 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20260421 | 15 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Apotex Corp. | Aizant Drug Research Solutions Pvt Ltd | 20260410 | 2 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND METFORMIN HCL EXTENDED-RELEASE TABLETS. DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 2014 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 20260409 | 1 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN AND SAXAGLIPTIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN AND SAXAGLIPTIN TABLETS. DAPAGLIFLOZIN AND SAXAGLIPTIN tablets, for oral use Initial U.S. Approval: 2017 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 20260408 | 1 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 20260408 | 2 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Cipla USA Inc. | Cipla Limited | MSN Laboratories Private Limited | CIPLA LIMITED GOA | 20260408 | 5 |
| 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 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260407 | 1 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20260407 | 11 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Macleods Pharmaceuticals Limited | 20260407 | 2 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Limited | 20260407 | 1 |
| Dapagliflozin Tablets | Zydus Lifesciences Limited | 20260406 | 6 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20260406 | 3 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20260402 | 14 |
| 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 | Sun Pharmaceutical Industries, Inc. | 20260331 | 2 |
| 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 | Macleods Pharmaceuticals Limited | 20260331 | 1 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Sandoz Inc | 20260331 | 1 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20260320 | 9 |
| 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 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20260318 | 14 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Biocon Pharma Inc. | Biocon Pharma Limited | Biocon Limited | Syngene International Limited | 20260212 | 12 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Teva Pharmaceuticals, Inc. | 20251031 | 5 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Ajanta Pharma USA Inc. | Ajanta Pharma Limited, Paithan | Ajanta Pharma Ltd., Dahej | 20250811 | 10 |
| 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 | Prasco Laboratories | AstraZeneca PLC | 20241220 | 7 |
| 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 | AstraZeneca Pharmaceuticals LP | AstraZeneca PLC | 20241220 | 38 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Prasco Laboratories | AstraZeneca PLC | 20241024 | 9 |
| These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014 | AstraZeneca Pharmaceuticals LP | 20241024 | 45 |
| These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014 | Cardinal Health 107, LLC | 20240829 | 20 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Bryant Ranch Prepack | 20240808 | 101 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | A-S Medication Solutions | 20240628 | 4 |
| These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | A-S Medication Solutions | 20240628 | 4 |
| These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014 | A-S Medication Solutions | 20231212 | 15 |