Application 077296
- Type
- ANDA
- Sponsor
- CELLTRION
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 125MG VALPROIC ACID | No | No |
| 002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 250MG VALPROIC ACID | No | No |
| 003 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 500MG VALPROIC ACID | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55648-973 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 55648-974 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 55648-975 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 64679-973 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Wockhardt USA LLC. | ANDA | Current |
| 64679-974 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Wockhardt USA LLC. | ANDA | Current |
| 64679-975 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Wockhardt USA LLC. | ANDA | Current |