| Baclofen Tablets USP Rx only | Product name | Preferred Pharmaceuticals Inc. | 2026-10-09 |
| BACLOFEN TABLETS, USP | Product name | REMEDYREPACK INC. | 2026-09-16 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2026-09-09 |
| Baclofen Oral Solution. These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Atlantic Biologicals Corp. | 2026-09-04 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2026-09-03 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2026-09-01 |
| BACLOFEN TABLETS USP | Product name | Par Health USA, LLC | 2026-08-24 |
| BACLOFEN TABLETS USP Rx only | Product name | Bryant Ranch Prepack | 2026-08-24 |
| Baclofen Oral Solution. These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Atlantic Biologicals Corp. | 2026-08-21 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2026-08-14 |
| Baclofen Tablets USP Rx only | Product name | REMEDYREPACK INC. | 2026-08-10 |
| Baclofen Oral Solution. These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Atlantic Biologicals Corp. | 2026-08-05 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Product name | REMEDYREPACK INC. | 2026-08-04 |
| These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Rosemont Pharmaceuticals LLC | 2026-08-04 |
| Baclofen Tablets USP Rx only | Product name | Cardinal Health 107, LLC | 2026-07-24 |
| Baclofen Oral Solution. These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Atlantic Biologicals Corp. | 2026-07-14 |
| Baclofen Tablets, USP Rx only | Product name | REMEDYREPACK INC. | 2026-06-30 |
| Baclofen Tablets USP Rx only | Product name | AvPAK | 2026-06-29 |
| BACLOFEN TABLETS, USP Rx only | Product name | NuCare Pharmaceuticals, Inc. | 2026-06-25 |
| Baclofen Tablets, USP Rx only | Product name | REMEDYREPACK INC. | 2026-06-01 |
| BACLOFEN TABLETS USP Rx only | Product name | Eywa Pharma Inc | Hibrow Healthcare Private Limited | 2026-05-16 |
| BACLOFEN TABLETS, USP | Product name | REMEDYREPACK INC. | 2026-05-12 |
| These highlights do not include all the information needed to use GABLOFEN ® safely and effectively. See full prescribing information for GABLOFEN. GABLOFEN (baclofen injection), for intrathecal use Initial U.S. Approval: 1992 | Product name | Piramal Critical Care Inc | 2026-05-07 |
| BACLOFEN TABLETS, USP Rx only | Product name | AvPAK | 2026-05-06 |
| Baclofen Oral Solution. These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Atlantic Biologicals Corp. | 2026-05-04 |
| Baclofen Tablets USP Rx only | Product name | Cardinal Health 107, LLC | 2026-05-01 |
| BACLOFEN TABLETS USP Rx only | Product name | Coupler LLC | Zydus Lifesciences Global FZE | 2026-04-23 |
| Baclofen Tablets, USP | Product name | Cardinal Health 107, LLC | 2026-04-22 |
| Baclofen Tablets, USP Rx only | Product name | Golden State Medical Supply, Inc. | 2026-04-21 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2026-04-14 |
| Cardinal Health 107, LLC human prescription drug label | Product name | Cardinal Health 107, LLC | 2026-04-13 |
| Baclofen Tablets USP Rx only | Product name | REMEDYREPACK INC. | 2026-04-10 |
| Medcore LLC human prescription drug label | Product name | Medcore LLC | 2026-04-01 |
| These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Rosemont Pharmaceuticals LLC | 2026-03-30 |
| BACLOFEN TABLETS, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-03-27 |
| BACLOFEN TABLETS, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-03-25 |
| BACLOFEN TABLETS, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-03-25 |
| BACLOFEN TABLETS, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-03-25 |
| Cardinal Health 107, LLC human prescription drug label | Product name | Cardinal Health 107, LLC | 2026-03-23 |
| BACLOFEN TABLETS USP Rx only | Product name | A-S Medication Solutions | 2026-03-23 |
| BACLOFEN TABLETS USP Rx only | Product name | A-S Medication Solutions | 2026-03-19 |
| Baclofen Tablets USP Rx only | Product name | Preferred Pharmaceuticals Inc. | 2026-03-19 |
| BACLOFEN TABLETS, USP Rx only | Product name | Preferred Pharmaceuticals Inc. | 2026-03-19 |
| Baclofen Tablets USP Rx only | Product name | Preferred Pharmaceuticals Inc. | 2026-03-18 |
| BACLOFEN TABLETS, USP Rx only | Product name | Preferred Pharmaceuticals Inc. | 2026-03-18 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Product name | Redpharm Drug | 2026-03-13 |
| These highlights do not include all the information needed to use OZOBAX ® DS safely and effectively. See full prescribing information for OZOBAX DS. OZOBAX DS (baclofen) oral solution Initial U.S. Approval: 1977 | Product name | Rosemont Pharmaceuticals LLC | 2026-03-13 |
| Baclofen Tablets, USP Rx only | Product name | Lifestar Pharma LLC | Mankind Pharma Limited | 2026-02-27 |
| Rx Only | Product name | A-S Medication Solutions | 2026-02-24 |
| BACLOFEN TABLETS, USP | Product name | Major Pharmaceuticals | 2026-02-13 |
| BACLOFEN TABLETS, USP Rx only | Product name | Bryant Ranch Prepack | 2026-02-05 |
| Baclofen Tablets, USP Rx only | Product name | Bryant Ranch Prepack | 2026-02-05 |
| Baclofen Tablets, USP | Product name | Cardinal Health 107, LLC | 2026-01-28 |
| Baclofen Tablets, USP | Product name | Preferred Pharmaceuticals, Inc. | 2026-01-26 |
| BACLOFEN TABLETS, USP | Product name | Advagen Pharma Limited | Rubicon Research Limited | 2026-01-23 |
| BACLOFEN TABLETS, USP | Product name | REMEDYREPACK INC. | 2026-01-21 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Product name | Preferred Pharmaceuticals Inc. | 2026-01-21 |
| BACLOFEN TABLETS USP Rx only | Product name | A-S Medication Solutions | 2026-01-20 |
| BACLOFEN TABLETS, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-01-12 |
| BACLOFEN TABLETS, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-01-12 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Product name | REMEDYREPACK INC. | 2026-01-12 |
| Baclofen Tablets, USP Rx only | Product name | Bryant Ranch Prepack | 2026-01-12 |
| Baclofen Tablets, USP | Product name | Major Pharmaceuticals | 2026-01-09 |
| These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Sarras Health LLC | 2026-01-08 |
| BACLOFEN TABLETS, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-01-07 |
| BACLOFEN TABLETS, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2026-01-06 |
| These highlights do not include all the information needed to use baclofen oral solution safely and effectively. See full prescribing information for baclofen oral solution. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Palmetto Pharmaceuticals Inc. | 2025-12-31 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Product name | REMEDYREPACK INC. | 2025-12-29 |
| Baclofen Tablets USP Rx only | Product name | Northwind Health Company, LLC | 2025-12-26 |
| BACLOFEN TABLETS, USP | Product name | Major Pharmaceuticals | 2025-12-23 |
| BACLOFEN TABLETS, USP Rx Only | Product name | Advanced Rx of Tennessee, LLC | 2025-12-18 |
| These highlights do not include all the information needed to use Baclofen safely and effectively. See full prescribing information for baclofen . Baclofen oral suspension Initial U.S. Approval: 1977 | Product name | Wilshire Pharmaceuticals, Inc. | 2025-12-16 |
| These highlights do not include all the information needed to use FLEQSUVY ® safely and effectively. See full prescribing information for FLEQSUVY ® . FLEQSUVY ® (baclofen oral suspension) Initial U.S. Approval: 1977 | Product name | Azurity Pharmaceuticals, Inc. | 2025-12-16 |
| Baclofen tablets, USP 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Product name | PHOENIX RX LLC | 2025-12-12 |
| BACLOFEN TABLETS, USP | Product name | Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc | 2025-12-11 |
| Baclofen Tablets, USP | Product name | Major Pharmaceuticals | 2025-12-10 |
| These highlights do not include all the information needed to use BACLOFEN INJECTION safely and effectively. See full prescribing information for BACLOFEN INJECTION BACLOFEN injection, for intrathecal use Initial U.S. Approval: 1992 | Product name | Advagen Pharma Limited | Immacule Lifesciences Private Limited | 2025-12-09 |
| BACLOFEN TABLETS, USP Rx Only | Product name | SOLA Pharmaceuticals, LLC | Rubicon Research Limited | 2025-12-08 |
| These highlights do not include all the information needed to use BACLOFEN ORAL SUSPENSION safely and effectively. See full prescribing information for BACLOFEN ORAL SUSPENSION. BACLOFEN oral suspension, for oral use Initial U.S. Approval: 1977 | Product name | ANI Pharmaceuticals, Inc. | 2025-12-04 |
| BACLOFEN TABLETS, USP | Product name | REMEDYREPACK INC. | 2025-12-03 |
| BACLOFEN TABLETS, USP Rx only | Product name | Proficient Rx LP | 2025-12-01 |
| Baclofen Tablets USP Rx only | Product name | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2025-11-24 |
| BACLOFEN TABLETS, USP | Product name | Advagen Pharma Limited | Rubicon Research Limited | 2025-11-20 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2025-11-17 |
| Baclofen Tablets, USP Rx only | Product name | Bryant Ranch Prepack | 2025-11-12 |
| Rx Only | Product name | Northstar RxLLC | Piramal Pharma Limited | 2025-11-05 |
| BACLOFEN TABLETS, USP Rx only | Product name | Proficient Rx LP | 2025-11-01 |
| Major Pharmaceuticals | Mankind Pharma Limited human prescription drug label | Product name | Major Pharmaceuticals | Mankind Pharma Limited | 2025-10-29 |
| BACLOFEN TABLETS, USP | Product name | Major Pharmaceuticals | 2025-10-22 |
| Baclofen Tablets USP Rx only | Product name | PD-Rx Pharmaceuticals, Inc. | 2025-10-20 |
| Baclofen Tablets, USP | Product name | PD-Rx Pharmaceuticals, Inc. | 2025-10-17 |
| BACLOFEN TABLETS, USP Rx only | Product name | PD-Rx Pharmaceuticals, Inc. | 2025-10-09 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Product name | Bryant Ranch Prepack | 2025-10-03 |
| Baclofen Tablets, USP Rx only | Product name | Bryant Ranch Prepack | 2025-10-03 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2025-10-01 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2025-09-30 |
| Baclofen | Product name | Marlex Pharmaceuticals Inc | 2025-09-22 |
| BACLOFEN TABLETS, USP Rx only | Product name | Proficient Rx LP | 2025-09-01 |
| Baclofen Tablets USP Rx only | Product name | Bryant Ranch Prepack | 2025-08-25 |
| BACLOFEN TABLETS, USP Rx only | Product name | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-08-13 |
| Baclofen Tablets, USP Rx Only 8480465/0525F | Product name | American Health Packaging | 2025-08-04 |
| Baclofen Tablets, USP Rx only | Product name | Method Pharmaceuticals LLC | 2025-07-23 |
| These highlights do not include all the information needed to use BACLOFEN ORAL SOLUTION safely and effectively. See full prescribing information for BACLOFEN ORAL SOLUTION. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Trifluent Pharma, LLC | 2025-07-21 |
| BACLOFEN TABLETS, USP | Product name | A-S Medication Solutions | 2025-07-15 |
| BACLOFEN TABLETS, USP | Product name | A-S Medication Solutions | 2025-07-15 |
| Baclofen Tablets, USP Rx only | Product name | Bryant Ranch Prepack | 2025-07-15 |
| Baclofen Tablets, USP Rx only | Product name | Aphena Pharma Solutions - Tennessee, LLC | 2025-07-11 |
| Baclofen Tablets, USP Rx only | Product name | Aphena Pharma Solutions - Tennessee, LLC | 2025-07-09 |
| BACLOFEN TABLETS, USP Rx only | Product name | REMEDYREPACK INC. | 2025-07-03 |
| Baclofen Tablets, USP Rx only | Product name | REMEDYREPACK INC. | 2025-07-01 |
| Baclofen Tablets, USP Rx only | Product name | Bryant Ranch Prepack | 2025-06-26 |
| These highlights do not include all the information needed to use BACLOFEN ORAL SOLUTION safely and effectively. See full prescribing information for BACLOFEN ORAL SOLUTION. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Advagen Pharma Ltd | 2025-06-12 |
| Baclofen Tablets USP Rx only | Product name | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2025-06-11 |
| Baclofen Tablets USP Rx only | Product name | HAWAII REPACK, INC. | 2025-06-11 |
| These highlights do not include all the information needed to use BACLOFEN ORAL SOLUTION safely and effectively. See full prescribing information for BACLOFEN ORAL SOLUTION. BACLOFEN oral solution Initial U.S. Approval: 1977 | Product name | Advagen Pharma Ltd., | RUBICON RESEARCH LIMITED | 2025-06-11 |
| BACLOFEN TABLETS USP Rx only | Product name | Eywa Pharma Inc | Hibrow Healthcare Private Limited | 2025-06-06 |
| These highlights do not include all the information needed to use BACLOFEN INJECTION safely and effectively. See full prescribing information for BACLOFEN INJECTION. BACLOFEN injection, for intrathecal use Initial U.S. Approval: 1992 | Product name | Sagent Pharmaceuticals | 2025-05-05 |
| BACLOFEN TABLETS, USP Rx only | Product name | Proficient Rx LP | 2025-04-01 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Product name | Bryant Ranch Prepack | 2025-02-21 |
| Baclofen Tablets USP Rx only | Product name | NuCare Pharmaceuticals,Inc. | 2025-02-05 |