| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20260529 | 103 |
| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20260514 | 104 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Preferred Pharmaceuticals Inc. | 20260513 | 3 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Jubilant Cadista Pharmaceuticals Inc. | Jubilant Generics Limited | Aavis Pharmaceuticals Inc. | 20260421 | 16 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20260407 | 101 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | NorthStar RxLLC | Macleods Pharmaceuticals Limited | 20260331 | 1 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | REMEDYREPACK INC. | 20260330 | 10 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | REMEDYREPACK INC. | 20260325 | 11 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | REMEDYREPACK INC. | 20260325 | 9 |
| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20260318 | 102 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit V | 20260312 | 9 |
| These highlights do not include all the information needed to use AVAPRO safely and effectively. See full prescribing information for AVAPRO. AVAPRO ® (irbesartan) tablets, for oral use Initial U.S. Approval: 1997 | Sanofi-Aventis U.S. LLC | Sanofi Winthrop Industrie | Eurofins Lancaster Laboratories, Inc | EUROAPI Hungary Ltd. | 20260219 | 21 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Teva Pharmaceuticals USA, Inc. | 20260128 | 16 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | REMEDYREPACK INC. | 20260127 | 10 |
| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | REMEDYREPACK INC. | 20260126 | 12 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | REMEDYREPACK INC. | 20260126 | 6 |
| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets, for oral use Initial U.S. Approval: 1997 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20260120 | 18 |
| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Solco Healthcare US, LLC | 20251231 | 11 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Aurobindo Pharma Limited | 20251219 | 14 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Unichem Pharmaceuticals (USA), Inc. | 20251218 | 12 |
| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Hikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc. | 20251201 | 21 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Aurobindo Pharma Limited | 20251121 | 11 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20251121 | 3 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals Private Limited | 20251113 | 16 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20251111 | 101 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20251110 | 7 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20251110 | 1009 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 20251107 | 1 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Hisun Pharmaceuticals USA Inc. | Han Hui Pharmaceuticals Co., Ltd. | 20251028 | 11 |
| These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE ® (irbesartan and hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 1997 | Sanofi-Aventis U.S. LLC | Sanofi Winthrop Industrie | EUROAPI Hungary Ltd. | Eurofins Lancaster Laboratories, Inc | CAMBREX PROFARMACO MILANO S.R.L. | 20251007 | 24 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20251002 | 1 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Solco Healthcare U.S., LLC | Prinston Pharmaceutical Inc. | Zhejiang Huahai Pharmaceutical Co., Ltd. | 20250930 | 7 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20250930 | 12 |
| IRBESARTAN tablets, for oral use These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. Initial U.S. Approval: 1997 | AvKARE | 20250911 | 4 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Macleods Pharmaceuticals Limited | Legacy Pharmaceutical Packaging LLC | 20250903 | 12 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Macleods Pharmaceuticals Limited | 20250902 | 15 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Unichem Pharmaceuticals (USA), Inc. | 20250813 | 13 |
| Irbesartan Tablets USP Rx only | AvPAK | 20250811 | 9 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | A-S Medication Solutions | 20250808 | 1 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | A-S Medication Solutions | 20250808 | 6 |
| IRBESARTAN TABLETS These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Chartwell RX, LLC | Chartwell Pharmaceuticals Congers, LLC. | 20250515 | 3 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral useInitial U.S. Approval: 1997 | Hisun Pharmaceuticals USA Inc. | Hisun Pharmaceutical (Hangzhou) Co., Ltd. | Hanhui Pharmaceuticals Co., Ltd. | 20250127 | 8 |
| IRBESARTAN | direct rx | 20250120 | 5 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Quality Care Products, LLC | 20241219 | 4 |
| These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets. Irbesartan and Hydrochlorothiazide Tablets, USP, for oral use Initial U.S. Approval: 1997 | Proficient Rx LP | 20241001 | 4 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20240708 | 101 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20240701 | 102 |
| These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide. Irbesartan and Hydrochlorothiazide tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20240520 | 3 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20240403 | 3 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | A-S Medication Solutions | 20231226 | 1 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | A-S Medication Solutions | 20231221 | 23 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets USP, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20231127 | 101 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20231127 | 101 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20231127 | 6 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20231122 | 17 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20231115 | 4 |
| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE Tablets, for oral use Initial U.S. Approval: 1997 | Alembic Pharmaceuticals Limited | 20230130 | 4 |
| These highlights do not include all the information needed to use IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN and HYDROCHLOROTHIAZIDE TABLETS.IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | REMEDYREPACK INC. | 20221227 | 1 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, USP for oral use Initial U.S. Approval: 1997 | Proficient Rx LP | 20220701 | 2 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Alembic Pharmaceuticals Limited | 20220603 | 3 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets USP, for oral use Initial U.S. Approval: 1997 | Proficient Rx LP | 20220502 | 2 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Bryant Ranch Prepack | 20211227 | 6 |
| These highlights do not include all the information needed to use Irbesartan safely and effectively. See full prescribing information for Irbesartan. Irbesartan tablets, for oral use Initial U.S. Approval: 1997 | A-S Medication Solutions | 20210614 | 6 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | ScieGen Pharmaceuticals, Inc. | 20210129 | 4 |
| These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1997 | Proficient Rx LP | 20210101 | 3 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, USP for oral use Initial U.S. Approval: 1997 | Proficient Rx LP | 20200101 | 4 |
| These highlights do not include all the information needed to use IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1997 | Proficient Rx LP | 20191101 | 3 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | A-S Medication Solutions | 20191002 | 2 |
| These highlights do not include all the information needed to use IRBESARTAN safely and effectively. See full prescribing information for IRBESARTAN. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | Proficient Rx LP | 20191001 | 2 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 | A-S Medication Solutions | 20190429 | 5 |
| These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, USP for oral use Initial U.S. Approval: 1997 | Camber Pharmaceuticals, Inc. | ScieGen Pharmaceuticals, Inc. | 20161006 | 1 |
| These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1997 | Physicians Total Care, Inc. | 20150507 | 2 |
| These highlights do not include all the information needed to use irbesartan and hydrochlorothiazide tablets USP safely and effectively. See full prescribing information for irbesartan and hydrochlorothiazide tablets USP. IRBESARTAN and HYDROCHLOROTHIAZIDE tablets USP for oral use Initial U.S. Approval: 1997 | Legacy Pharmaceutical Packaging | 20121005 | 4 |
| AVAPRO ® (irbesartan) Tablets | Physicians Total Care, Inc. | 20111220 | 2 |
| These highlights do not include all the information needed to use AVALIDE safely and effectively. See full prescribing information for AVALIDE. AVALIDE (irbesartan and hydrochlorothiazide) tablet for oral use AVALIDE (irbesartan and hydrochlorothiazide) tablet, film coated for oral use Initial U.S. Approval: 1997 | Physicians Total Care, Inc. | 20100119 | 2 |