Application 214643
- Type
- ANDA
- Sponsor
- UNICHEM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 250MG VALPROIC ACID | No | No |
| 002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG VALPROIC ACID | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-380 | divalproex sodium | divalproex sodium | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-380 | divalproex sodium | divalproex sodium | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-381 | divalproex sodium | divalproex sodium | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-381 | divalproex sodium | divalproex sodium | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |