Application 072234
- Type
- ANDA
- Sponsor
- IVAX SUB TEVA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BACLOFEN | BACLOFEN | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0172-4096 | Baclofen | Baclofen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-4096 | Baclofen | Baclofen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-4096 | Baclofen | Baclofen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0172-4096 | Baclofen | Baclofen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-3541 | Baclofen | Baclofen | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-3541 | Baclofen | Baclofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-3541 | Baclofen | Baclofen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-3365 | Baclofen | Baclofen | Major Pharmaceuticals | ANDA | Current |
| 42254-061 | Baclofen | Baclofen | Rebel Distributors Corp | ANDA | Current |
| 50090-0564 | Baclofen | Baclofen | A-S Medication Solutions | ANDA | Current |
| 50090-0564 | Baclofen | Baclofen | A-S Medication Solutions | ANDA | Current |
| 50436-9022 | Baclofen | Baclofen | Unit Dose Services | ANDA | Current |
| 50436-9022 | Baclofen | Baclofen | Unit Dose Services | ANDA | Current |
| 52959-733 | Baclofen | Baclofen | H.J. Harkins Company, Inc. | ANDA | Current |
| 55289-757 | Baclofen | Baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-757 | Baclofen | Baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-757 | Baclofen | Baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-757 | Baclofen | Baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-757 | Baclofen | Baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-757 | Baclofen | Baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 61919-026 | BACLOFEN | BACLOFEN | Direct Rx | ANDA | Current |
| 61919-026 | BACLOFEN | BACLOFEN | Direct Rx | ANDA | Current |
| 63187-147 | Baclofen | Baclofen | Proficient Rx LP | ANDA | Current |
| 63187-147 | Baclofen | Baclofen | Proficient Rx LP | ANDA | Current |
| 63187-147 | Baclofen | Baclofen | Proficient Rx LP | ANDA | Current |
| 63629-6883 | Baclofen | Baclofen | Bryant Ranch Prepack | ANDA | Current |
| 63629-6883 | Baclofen | Baclofen | Bryant Ranch Prepack | ANDA | Current |
| 68788-9846 | Baclofen | Baclofen | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9846 | Baclofen | Baclofen | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0547 | Baclofen | Baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-0547 | Baclofen | Baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-1515 | Baclofen | Baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-1515 | Baclofen | Baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-1515 | Baclofen | Baclofen | REMEDYREPACK INC. | ANDA | Current |
| 80425-0080 | Baclofen | Baclofen 10mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0080 | Baclofen | Baclofen 10mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0080 | Baclofen | Baclofen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0080 | Baclofen | Baclofen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0080 | Baclofen | Baclofen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |