Application 078705
- Type
- ANDA
- Sponsor
- WOCKHARDT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG VALPROIC ACID | No | No |
| 002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 250MG VALPROIC ACID | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55648-724 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 55648-725 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 64679-724 | Divalproex Sodium | Divalproex Sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-724 | Divalproex Sodium | Divalproex Sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-724 | Divalproex Sodium | Divalproex Sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-725 | Divalproex Sodium | Divalproex Sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-725 | Divalproex Sodium | Divalproex Sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-725 | Divalproex Sodium | Divalproex Sodium | Wockhardt USA LLC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 22625 | ORIG | 2011-12-09 |