Application 205074
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
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 |
|---|
| 46708-181 | Zolmitriptan | Zolmitriptan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-181 | Zolmitriptan | Zolmitriptan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-182 | Zolmitriptan | Zolmitriptan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-182 | Zolmitriptan | Zolmitriptan | Alembic Pharmaceuticals Limited | ANDA | Current |
| 64980-256 | Zolmitriptan | Zolmitriptan | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-256 | Zolmitriptan | Zolmitriptan | Rising Pharmaceuticals, I | ANDA | Current |
| 64980-257 | Zolmitriptan | Zolmitriptan | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-257 | Zolmitriptan | Zolmitriptan | Rising Pharmaceuticals, I | ANDA | Current |