| These highlights do not include all the information needed to use PIRFENIDONE CAPSULES safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. PIRFENIDONE capsules, for oral use Initial U.S. Approval: 2014 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260422 | 1 |
| PIRFENIDONE capsules, for oral use . These highlights do not include all the information needed to usePIRFENIDONE CAPSULES safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. Initial U.S. Approval: 2014 | AvKARE | 20260114 | 3 |
| PIRFENIDONE tablets, for oral use These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. Initial U.S. Approval: 2014 | AvKARE | 20260114 | 2 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively.See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Accord Healthcare Inc. | Intas Pharmaceuticals Limited | 20251217 | 9 |
| These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules and film-coated tablets, for oral use Initial U.S. Approval: 2014 | Genentech, Inc. | F. Hoffmann-La Roche AG | 20251205 | 21 |
| PIRFENIDONE TABLETS. These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Golden State Medical Supply, Inc. | 20251124 | 2 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Bryant Ranch Prepack | 20251030 | 100 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Bryant Ranch Prepack | 20251030 | 100 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Apotex Corp. | Apotex Inc. | 20250922 | 4 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE film-coated tablets, for oral use Initial U.S. Approval: 2014 | ANI Pharmaceuticals, Inc. | Novitium Pharma LLC | 20250917 | 6 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20250813 | 1 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Bryant Ranch Prepack | 20250807 | 105 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Bryant Ranch Prepack | 20250807 | 101 |
| These highlights do not include all the information needed to use PIRFENIDONE CAPSULES and TABLETS safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES and TABLETS. PIRFENIDONE capsules and film-coated tablets, for oral use Initial U.S. Approval: 2014 | Laurus Labs Limited | Laurus Labs Limited (VSP2) | 20250722 | 4 |
| These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules and film-coated tablets, for oral use Initial U.S. Approval: 2014 | Legacy Pharma USA Inc. | Ferndale Laboratories, Inc. | 20250609 | 1 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Micro Labs Limited | 20250604 | 4 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Amneal Pharmaceuticals NY LLC | 20250530 | 11 |
| These highlights do not include all the information needed to use PIRFENIDONE CAPSULES safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. PIRFENIDONE capsules, for oral use Initial U.S. Approval: 2014 | Macleods Pharmaceuticals Limited | 20250328 | 1 |
| These highlights do not include all the information needed to use PIRFENIDONE CAPSULES safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. PIRFENIDONE capsules, for oral use Initial U.S. Approval: 2014 | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC | Amneal Pharmaceuticals Private Limited | 20250228 | 5 |
| These highlights do not include all the information needed to use PIRFENIDONE CAPSULES safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. PIRFENIDONE capsules, for oral use Initial U.S. Approval: 2014 | Amneal Pharmaceuticals NY LLC | 20241104 | 3 |
| These highlights do not include all the information needed to use PIRFENIDONE CAPSULES safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. PIRFENIDONE capsules, for oral use Initial U.S. Approval: 2014 | Sandoz Inc | 20241030 | 6 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Teva Pharmaceuticals, Inc. | 20241021 | 5 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE film-coated tablets, for oral use Initial U.S. Approval: 2014 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc. | 20240723 | 4 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE film-coated tablets, for oral use Initial U.S. Approval: 2014 | Northstar Rx LLC | MSN LABORATORIES PRIVATE LIMITED | 20240308 | 1 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20231206 | 9 |
| These highlights do not include all the information needed to use PIRFENIDONE, safely and effectively. See full prescribing information for PIRFENIDONE. PIRFENIDONE capsules, for oral use PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | ScieGen Pharmaceuticals, Inc. | 20231109 | 2 |
| These highlights do not include all the information needed to use PIRFENIDONE, safely and effectively. See full prescribing information for PIRFENIDONE. PIRFENIDONE capsules, for oral use PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | ScieGen Pharmaceuticals, Inc. | 20231108 | 2 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE film-coated tablets, for oral use Initial U.S. Approval: 2014 | MAJOR PHARMACEUTICALS | MSN Pharmaceuticals Inc. | 20231031 | 1 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE film-coated tablets, for oral use Initial U.S. Approval: 2014 | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 20230511 | 2 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Sandoz Inc | 20230430 | 4 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC | 20230410 | 2 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Limited | 20230330 | 3 |
| These highlights do not include all the information needed to use PIRFENIDONE CAPSULES, safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. PIRFENIDONE capsules, for oral use Initial U.S. Approval: 2014 | EXELAN PHARMACEUTICALS INC. | ScieGen Pharmaceuticals, INC. | 20230120 | 2 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS, safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | Cipla USA Inc. | ScieGen Pharmaceuticals, INC. | 20220826 | 3 |
| These highlights do not include all the information needed to use PIRFENIDONE TABLETS, safely and effectively. See full prescribing information for PIRFENIDONE TABLETS. PIRFENIDONE tablets, for oral use Initial U.S. Approval: 2014 | EXELAN PHARMACEUTICALS INC. | ScieGen Pharmaceuticals, INC. | 20220808 | 2 |
| These highlights do not include all the information needed to use PIRFENIDONE CAPSULES, safely and effectively. See full prescribing information for PIRFENIDONE CAPSULES. PIRFENIDONE capsules, for oral use Initial U.S. Approval: 2014 | Cipla USA Inc. | ScieGen Pharmaceuticals, INC. | 20220803 | 1 |
| These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules, for oral use Initial U.S. Approval: 2014 | InterMune, Inc. | 20141028 | 1 |