Application 213003
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIAZOLAM | TRIAZOLAM | TABLET;ORAL | 0.125MG | No | No |
| 002 | TRIAZOLAM | TRIAZOLAM | TABLET;ORAL | 0.25MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70710-1289 | Triazolam | Triazolam | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1521 | Triazolam | Triazolam | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70771-1162 | Triazolam | Triazolam | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1576 | Triazolam | Triazolam | Zydus Lifesciences Limited | ANDA | Current |