| Baclofen Tablets, USP Rx only | REMEDYREPACK INC. | 20260601 | 6 |
| BACLOFEN TABLETS, USP | REMEDYREPACK INC. | 20260512 | 1 |
| 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 | Piramal Critical Care Inc | 20260507 | 43 |
| BACLOFEN TABLETS, USP Rx only | AvPAK | 20260506 | 5 |
| 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 | Atlantic Biologicals Corp. | 20260504 | 2 |
| Baclofen Tablets USP Rx only | Cardinal Health 107, LLC | 20260501 | 3 |
| BACLOFEN TABLETS USP Rx only | Coupler LLC | Zydus Lifesciences Global FZE | 20260423 | 1 |
| Baclofen Tablets, USP | Cardinal Health 107, LLC | 20260422 | 11 |
| Baclofen Tablets, USP Rx only | Golden State Medical Supply, Inc. | 20260421 | 2 |
| BACLOFEN TABLETS, USP Rx only | REMEDYREPACK INC. | 20260414 | 8 |
| a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c | Cardinal Health 107, LLC | 20260413 | 2 |
| Baclofen Tablets USP Rx only | REMEDYREPACK INC. | 20260410 | 7 |
| 13eca70c-3cc8-4317-83cf-ade3327e48c0 | Medcore LLC | 20260401 | 1 |
| BACLOFEN TABLETS, USP | PD-Rx Pharmaceuticals, Inc. | 20260327 | 4 |
| BACLOFEN TABLETS, USP | PD-Rx Pharmaceuticals, Inc. | 20260325 | 10 |
| BACLOFEN TABLETS, USP | PD-Rx Pharmaceuticals, Inc. | 20260325 | 8 |
| BACLOFEN TABLETS, USP | PD-Rx Pharmaceuticals, Inc. | 20260325 | 10 |
| BACLOFEN TABLETS USP Rx only | A-S Medication Solutions | 20260323 | 1 |
| BACLOFEN TABLETS USP Rx only | A-S Medication Solutions | 20260319 | 7 |
| Baclofen Tablets USP Rx only | Preferred Pharmaceuticals Inc. | 20260319 | 3 |
| BACLOFEN TABLETS, USP Rx only | Preferred Pharmaceuticals Inc. | 20260319 | 3 |
| Baclofen Tablets USP Rx only | Preferred Pharmaceuticals Inc. | 20260318 | 3 |
| BACLOFEN TABLETS, USP Rx only | Preferred Pharmaceuticals Inc. | 20260318 | 3 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Redpharm Drug | 20260313 | 1 |
| 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 | Rosemont Pharmaceuticals LLC | 20260313 | 2 |
| Baclofen Tablets, USP Rx only | Lifestar Pharma LLC | Mankind Pharma Limited | 20260227 | 8 |
| Rx Only | A-S Medication Solutions | 20260224 | 1 |
| BACLOFEN TABLETS, USP | Major Pharmaceuticals | 20260213 | 3 |
| BACLOFEN TABLETS, USP Rx only | Bryant Ranch Prepack | 20260205 | 1 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20260205 | 1 |
| Baclofen Tablets, USP | Preferred Pharmaceuticals, Inc. | 20260126 | 10 |
| BACLOFEN TABLETS, USP | Advagen Pharma Limited | Rubicon Research Limited | 20260123 | 7 |
| BACLOFEN TABLETS, USP | REMEDYREPACK INC. | 20260121 | 2 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Preferred Pharmaceuticals Inc. | 20260121 | 2 |
| BACLOFEN TABLETS USP Rx only | A-S Medication Solutions | 20260120 | 12 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | REMEDYREPACK INC. | 20260112 | 5 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20260112 | 103 |
| Baclofen Tablets, USP | Major Pharmaceuticals | 20260109 | 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 | Sarras Health LLC | 20260108 | 2 |
| 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 | Palmetto Pharmaceuticals Inc. | 20251231 | 2 |
| Baclofen Tablets USP Rx only | Northwind Health Company, LLC | 20251226 | 4 |
| BACLOFEN TABLETS, USP Rx Only | Advanced Rx of Tennessee, LLC | 20251218 | 2 |
| 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 | Wilshire Pharmaceuticals, Inc. | 20251216 | 3 |
| 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 | Azurity Pharmaceuticals, Inc. | 20251216 | 4 |
| Baclofen tablets, USP 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | PHOENIX RX LLC | 20251212 | 1 |
| BACLOFEN TABLETS, USP | Upsher-Smith Laboratories, LLC | Bora Pharmaceuticals, Inc | 20251211 | 8 |
| 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 | Advagen Pharma Limited | Immacule Lifesciences Private Limited | 20251209 | 6 |
| BACLOFEN TABLETS, USP Rx Only | SOLA Pharmaceuticals, LLC | Rubicon Research Limited | 20251208 | 3 |
| 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 | ANI Pharmaceuticals, Inc. | 20251204 | 2 |
| BACLOFEN TABLETS, USP Rx only | Proficient Rx LP | 20251201 | 5 |
| Baclofen Tablets USP Rx only | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20251124 | 1 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20251112 | 101 |
| Rx Only | Northstar RxLLC | Piramal Pharma Limited | 20251105 | 17 |
| f328296e-0713-4acb-bcb5-c10d7838d380 | Major Pharmaceuticals | Mankind Pharma Limited | 20251029 | 1 |
| Baclofen Tablets USP Rx only | PD-Rx Pharmaceuticals, Inc. | 20251020 | 27 |
| Baclofen Tablets, USP | PD-Rx Pharmaceuticals, Inc. | 20251017 | 26 |
| BACLOFEN TABLETS, USP Rx only | PD-Rx Pharmaceuticals, Inc. | 20251009 | 7 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Bryant Ranch Prepack | 20251003 | 1 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20251003 | 1 |
| BACLOFEN TABLETS, USP Rx only | REMEDYREPACK INC. | 20251001 | 2 |
| BACLOFEN TABLETS, USP Rx only | REMEDYREPACK INC. | 20250930 | 2 |
| Baclofen | Marlex Pharmaceuticals Inc | 20250922 | 9 |
| Baclofen Tablets USP Rx only | Bryant Ranch Prepack | 20250825 | 104 |
| BACLOFEN TABLETS, USP Rx only | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 20250813 | 2 |
| Baclofen Tablets, USP Rx Only 8480465/0525F | American Health Packaging | 20250804 | 4 |
| Baclofen Tablets, USP Rx only | Method Pharmaceuticals LLC | 20250723 | 2 |
| 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 | Trifluent Pharma, LLC | 20250721 | 2 |
| BACLOFEN TABLETS, USP | A-S Medication Solutions | 20250715 | 1 |
| BACLOFEN TABLETS, USP | A-S Medication Solutions | 20250715 | 2 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20250715 | 1 |
| Baclofen Tablets, USP Rx only | Aphena Pharma Solutions - Tennessee, LLC | 20250711 | 1 |
| Baclofen Tablets, USP Rx only | Aphena Pharma Solutions - Tennessee, LLC | 20250709 | 1 |
| BACLOFEN TABLETS, USP Rx only | REMEDYREPACK INC. | 20250703 | 1 |
| Baclofen Tablets, USP Rx only | REMEDYREPACK INC. | 20250701 | 1 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20250626 | 100 |
| 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 | Advagen Pharma Ltd | 20250612 | 2 |
| Baclofen Tablets USP Rx only | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20250611 | 3 |
| Baclofen Tablets USP Rx only | HAWAII REPACK, INC. | 20250611 | 1 |
| 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 | Advagen Pharma Ltd., | RUBICON RESEARCH LIMITED | 20250611 | 1 |
| BACLOFEN TABLETS USP Rx only | Eywa Pharma Inc | Hibrow Healthcare Private Limited | 20250606 | 6 |
| 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 | Sagent Pharmaceuticals | 20250505 | 2 |
| BACLOFEN TABLETS, USP Rx only | Proficient Rx LP | 20250401 | 1 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Bryant Ranch Prepack | 20250221 | 101 |
| Baclofen Tablets USP Rx only | NuCare Pharmaceuticals,Inc. | 20250205 | 3 |
| Baclofen Tablets, USP Rx only | XLCare Pharmaceuticals Inc. | Innogenix LLC | 20250205 | 2 |
| BACLOFEN TABLETS, USP Rx only | Advanced Rx of Tennessee, LLC | 20250130 | 1 |
| Baclofen | Direct_Rx | 20250128 | 4 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Bryant Ranch Prepack | 20250122 | 100 |
| Baclofen tablets, USP 5 mg 10 mg 20 mg Muscle Relaxant, Antispastic Rx only Prescribing Information | Bryant Ranch Prepack | 20250122 | 100 |
| Baclofen Tablets USP Rx only | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 20250115 | 2 |
| Baclofen Tablets USP Rx only | AvPAK | 20250109 | 4 |
| Baclofen Tablets, USP Rx only | NuCare Pharmaceuticals,Inc. | 20250103 | 3 |
| 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 | Nexus Pharmaceuticals LLC | Immacule Lifesciences Private Limited | 20250102 | 2 |
| Baclofen Tablets | Advanced Rx of Tennessee, LLC | 20241231 | 7 |
| Baclofen Tablets | Advanced Rx of Tennessee, LLC | 20241231 | 6 |
| Baclofen Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 20241231 | 7 |
| Baclofen Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 20241231 | 8 |
| Baclofen Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 20241231 | 7 |
| Baclofen Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 20241231 | 4 |
| Baclofen Tablets USP Rx only | Advanced Rx of Tennessee, LLC | 20241229 | 2 |
| Baclofen Tablets USP Rx only | Advanced Rx of Tennessee, LLC | 20241228 | 1 |
| BACLOFEN TABLETS, USP Rx only | NuCare Pharmaceuticals, Inc. | 20241224 | 4 |
| Baclofen Tablets USP Rx only | Quality Care Products, LLC | 20241219 | 4 |
| Baclofen tablets, USP Rx only | Advanced Rx of Tennessee, LLC | 20241219 | 2 |
| BACLOFEN TABLETS, USP | Bryant Ranch Prepack | 20241212 | 101 |
| BACLOFEN TABLETS, USP | Bryant Ranch Prepack | 20241205 | 104 |
| BACLOFEN TABLETS, USP | Bryant Ranch Prepack | 20241205 | 104 |
| BACLOFEN TABLETS, USP | Bryant Ranch Prepack | 20241205 | 104 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20241127 | 101 |
| Baclofen 20mg Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 20241115 | 2 |
| BACLOFEN TABLETS, USP | Par Health USA, LLC | 20241107 | 22 |
| Baclofen Tablets, USP Rx Only | Chartwell RX, LLC | 20241010 | 4 |
| Baclofen Tablets, USP Rx only | NCS HealthCare of KY, LLC dba Vangard Labs | 20241004 | 2 |
| Baclofen Tablets, USP Rx only | Marlex Pharmaceuticals, Inc. | 20241003 | 2 |
| BACLOFEN TABLETS USP | Proficient Rx LP | 20241001 | 7 |
| BACLOFEN TABLETS USP Rx only | Proficient Rx LP | 20241001 | 5 |
| BACLOFEN TABLETS, USP Rx only | Bryant Ranch Prepack | 20240916 | 1 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20240912 | 101 |
| BACLOFEN TABLETS USP Rx only | Bryant Ranch Prepack | 20240905 | 5 |
| Baclofen Tablets, USP Rx only | Bryant Ranch Prepack | 20240903 | 1 |