| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | American Health Packaging | 20260529 | 1 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc. | 20260206 | 4 |
| DABIGATRAN ETEXILATE capsules, for oral use These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. Initial U.S. Approval: 2010 | AvKARE | 20260113 | 2 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | NorthStar RxLLC | Hetero Labs Limited Unit III | 20251203 | 1 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Alembic Pharmaceuticals Limited | 20251120 | 3 |
| DABIGATRAN ETEXILATE capsules, for oral use These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. Initial U.S. Approval: 2010 | AvPAK | 20251117 | 2 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20251031 | 13 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | A-S Medication Solutions | 20250922 | 1 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | A-S Medication Solutions | 20250919 | 1 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20250917 | 26 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Aurobindo Pharma Limited | 20250801 | 3 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III | 20250730 | 8 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Mylan Pharmaceuticals Inc. | 20250730 | 4 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Dr.Reddys Laboratories Inc | Dr. Reddys Laboratories Limited (SEZ UNIT) | 20250724 | 21 |
| These highlights do not include all the information needed to use PRADAXA Oral Pellets safely and effectively. See full prescribing information for PRADAXA Oral Pellets. PRADAXA ® (dabigatran etexilate) oral pellets Initial U.S. Approval: 2010 | Boehringer Ingelheim Pharmaceuticals, Inc. | Bidachem S.p.a. | Boehringer Ingelheim Pharma GmbH and Co. KG | Catalent Germany Schorndorf GmbH | Sixarp, LLC | 20250627 | 7 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN E TEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Apotex Corp. | Apotex Inc. | 20250626 | 4 |
| These highlights do not include all the information needed to use PRADAXA Capsules safely and effectively. See full prescribing information for PRADAXA Capsules. PRADAXA ® (dabigatran etexilate) capsules, for oral use Initial U.S. Approval: 2010 | Boehringer Ingelheim Pharmaceuticals Inc. | Boehringer Ingelheim Pharma GmbH and Co. KG | Bidachem S.p.a. | Sixarp, LLC - Praxis Packaging Solutions | 20250625 | 48 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | Major Pharmaceuticals | Alkem Laboratories Limited | 20250612 | 2 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | A-S Medication Solutions | 20250409 | 1 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN ETEXILATE capsules, for oral use Initial U.S. Approval: 2010 | A-S Medication Solutions | 20250409 | 1 |
| These highlights do not include all the information needed to use DABIGATRAN ETEXILATE CAPSULES safely and effectively. See full prescribing information for DABIGATRAN ETEXILATE CAPSULES. DABIGATRAN etexilate capsules, for oral use Initial U.S. Approval: 2010 | XLCare Pharmaceuticals, Inc. | Ascent Pharmaceuticals, Inc. | 20230815 | 1 |
| These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA. PRADAXA® (dabigatran etexilate) capsules, for oral use Initial U.S. Approval: 2010 | A-S Medication Solutions | 20210616 | 8 |