Application 213181
- Type
- ANDA
- Sponsor
- AJANTA PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 125MG VALPROIC ACID | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27241-115 | Divalproex sodium | Divalproex sodium | Ajanta Pharma Limited | ANDA | Current |
| 27241-115 | Divalproex sodium | Divalproex sodium | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-115 | Divalproex sodium | Divalproex sodium | Ajanta Pharma Limited | ANDA | Current |
| 27241-115 | Divalproex sodium | Divalproex sodium | Ajanta Pharma USA Inc. | ANDA | Current |
| 27241-115 | Divalproex sodium | Divalproex sodium | Ajanta Pharma Limited | ANDA | Current |
| 27241-115 | Divalproex sodium | Divalproex sodium | Ajanta Pharma Limited | ANDA | Current |
| 60687-654 | Divalproex sodium | Divalproex sodium | American Health Packaging | ANDA | Current |
| 70518-3457 | Divalproex sodium | Divalproex sodium | REMEDYREPACK INC. | ANDA | Current |