Application 209795
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLOBAZAM | CLOBAZAM | TABLET;ORAL | 10MG | No | No |
| 002 | CLOBAZAM | CLOBAZAM | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-887 | Clobazam | Clobazam | NorthStar RxLLC | ANDA | Current |
| 16714-887 | Clobazam | Clobazam | NorthStar RxLLC | ANDA | Current |
| 16714-887 | Clobazam | Clobazam | NorthStar RxLLC | ANDA | Current |
| 16714-888 | Clobazam | Clobazam | NorthStar RxLLC | ANDA | Current |
| 16714-888 | Clobazam | Clobazam | NorthStar RxLLC | ANDA | Current |
| 16714-888 | Clobazam | Clobazam | NorthStar RxLLC | ANDA | Current |
| 31722-639 | Clobazam | Clobazam | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-640 | Clobazam | Clobazam | Camber Pharmaceuticals, Inc. | ANDA | Current |