Application 202890
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZOLMITRIPTAN | ZOLMITRIPTAN | TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG | No | No |
| 002 | ZOLMITRIPTAN | ZOLMITRIPTAN | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65841-767 | Zolmitriptan | Zolmitriptan | Cadila Healthcare Limited | ANDA | Current |
| 65841-767 | Zolmitriptan | Zolmitriptan | Zydus Lifesciences Limited | ANDA | Current |
| 65841-767 | Zolmitriptan | Zolmitriptan | Cadila Healthcare Limited | ANDA | Current |
| 65841-768 | Zolmitriptan | Zolmitriptan | Cadila Healthcare Limited | ANDA | Current |
| 65841-768 | Zolmitriptan | Zolmitriptan | Zydus Lifesciences Limited | ANDA | Current |
| 65841-768 | Zolmitriptan | Zolmitriptan | Cadila Healthcare Limited | ANDA | Current |
| 68382-715 | Zolmitriptan | Zolmitriptan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-715 | Zolmitriptan | Zolmitriptan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-715 | Zolmitriptan | Zolmitriptan | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-717 | Zolmitriptan | Zolmitriptan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-717 | Zolmitriptan | Zolmitriptan | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-717 | Zolmitriptan | Zolmitriptan | Zydus Pharmaceuticals USA Inc. | ANDA | Current |