Application 208785
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0526 | Clobazam | Clobazam | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0526 | Clobazam | Clobazam | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0527 | Clobazam | Clobazam | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0527 | Clobazam | Clobazam | West-Ward Pharmaceuticals Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56474 | ORIG | 2018-11-15 |