Application 212067
- Type
- ANDA
- Sponsor
- UNICHEM LABS LTD
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-343 | Baclofen | Baclofen | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-343 | Baclofen | Baclofen | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-344 | Baclofen | Baclofen | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-344 | Baclofen | Baclofen | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |