Application 214099
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BACLOFEN | BACLOFEN | TABLET;ORAL | 10MG | No | No |
| 002 | BACLOFEN | BACLOFEN | TABLET;ORAL | 20MG | No | No |
| 003 | BACLOFEN | BACLOFEN | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 55700-974 | BACLOFEN | BACLOFEN | Quality Care Products, LLC | ANDA | Current |
| 55700-974 | BACLOFEN | BACLOFEN | Quality Care Products, LLC | ANDA | Current |
| 55700-974 | BACLOFEN | BACLOFEN | Quality Care Products, LLC | ANDA | Current |
| 59651-394 | BACLOFEN | BACLOFEN | Aurobindo Pharma Limited | ANDA | Current |
| 59651-394 | BACLOFEN | BACLOFEN | Aurobindo Pharma Limited | ANDA | Current |
| 59651-395 | BACLOFEN | BACLOFEN | Aurobindo Pharma Limited | ANDA | Current |
| 59651-395 | BACLOFEN | BACLOFEN | Aurobindo Pharma Limited | ANDA | Current |
| 68071-2841 | BACLOFEN | BACLOFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2841 | BACLOFEN | BACLOFEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-3467 | BACLOFEN | BACLOFEN | REMEDYREPACK INC. | ANDA | Current |
| 70518-3467 | BACLOFEN | BACLOFEN | REMEDYREPACK INC. | ANDA | Current |
| 70518-3467 | BACLOFEN | BACLOFEN | REMEDYREPACK INC. | ANDA | Current |
| 76420-241 | BACLOFEN | BACLOFEN | Asclemed USA, Inc. | ANDA | Current |
| 76420-242 | BACLOFEN | BACLOFEN | Asclemed USA, Inc. | ANDA | Current |