Application 210201
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MISOPROSTOL | MISOPROSTOL | TABLET;ORAL | 0.1MG | No | No |
| 002 | MISOPROSTOL | MISOPROSTOL | TABLET;ORAL | 0.2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70710-1006 | Misoprostol | Misoprostol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70710-1007 | Misoprostol | Misoprostol | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1496 | Misoprostol | Misoprostol | Cadila Healthcare Limited | ANDA | Current |
| 70771-1497 | Misoprostol | Misoprostol | Cadila Healthcare Limited | ANDA | Current |