Application 202956
- Type
- ANDA
- Sponsor
- JUBILANT GENERICS
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59746-461 | Zolmitriptan OD | Zolmitriptan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-461 | Zolmitriptan OD | Zolmitriptan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-462 | Zolmitriptan OD | Zolmitriptan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-462 | Zolmitriptan OD | Zolmitriptan | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32341 | ORIG | 2015-10-02 |