Application 072235
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BACLOFEN | BACLOFEN | TABLET;ORAL | 20MG | No | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0172-4097 | Baclofen | Baclofen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-4097 | Baclofen | Baclofen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-4097 | Baclofen | Baclofen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-4097 | Baclofen | Baclofen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-3542 | Baclofen | Baclofen | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-3542 | Baclofen | Baclofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-3542 | Baclofen | Baclofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-5222 | Baclofen | Baclofen | Major Pharmaceuticals | ANDA | Current |
| 42254-029 | Baclofen | Baclofen | Rebel Distributors Corp | ANDA | Current |
| 50090-2109 | Baclofen | Baclofen | A-S Medication Solutions | ANDA | Current |
| 50436-9023 | Baclofen | Baclofen | Unit Dose Services | ANDA | Current |
| 52959-677 | Baclofen | Baclofen | H.J. Harkins Company, Inc. | ANDA | Current |
| 55700-236 | Baclofen | Baclofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-027 | BACLOFEN | BACLOFEN | Direct Rx | ANDA | Current |
| 61919-027 | BACLOFEN | BACLOFEN | Direct Rx | ANDA | Current |
| 63187-274 | Baclofen | Baclofen | Proficient Rx LP | ANDA | Current |
| 63187-274 | Baclofen | Baclofen | Proficient Rx LP | ANDA | Current |
| 63187-274 | Baclofen | Baclofen | Proficient Rx LP | ANDA | Current |
| 68071-4905 | Baclofen | Baclofen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4905 | Baclofen | Baclofen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6903 | Baclofen | Baclofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6903 | Baclofen | Baclofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0411 | Baclofen | Baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-0411 | Baclofen | Baclofen | REMEDYREPACK INC. | ANDA | Current |