Application 021231
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOMIG-ZMT | ZOLMITRIPTAN | TABLET, ORALLY DISINTEGRATING;ORAL | 2.5MG | Yes | No |
| 002 | ZOMIG-ZMT | ZOLMITRIPTAN | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-0691 | Zolmitriptan Orally Disintegrating | Zolmitriptan | Impax Generics | NDA | Current |
| 0115-0692 | Zolmitriptan Orally Disintegrating | Zolmitriptan | Impax Generics | NDA | Current |
| 64896-691 | ZOMIG ZMT | Zolmitriptan | Impax Specialty Pharma | NDA | Current |
| 64896-691 | ZOMIG ZMT | Zolmitriptan | Amneal Pharmaceuticals | NDA | Current |
| 64896-691 | ZOMIG ZMT | Zolmitriptan | Amneal Pharmaceuticals | NDA | Current |
| 64896-691 | ZOMIG ZMT | Zolmitriptan | Amneal Pharmaceuticals | NDA | Current |
| 64896-692 | ZOMIG ZMT | Zolmitriptan | Impax Specialty Pharma | NDA | Current |
| 64896-692 | ZOMIG ZMT | Zolmitriptan | Amneal Pharmaceuticals | NDA | Current |
| 64896-692 | ZOMIG ZMT | Zolmitriptan | Amneal Pharmaceuticals | NDA | Current |
| 64896-692 | ZOMIG ZMT | Zolmitriptan | Amneal Pharmaceuticals | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57076 | SUPPL | 2018-12-31 |
| 57031 | SUPPL | 2018-12-26 |
| 36422 | SUPPL | 2012-09-18 |
| 27153 | SUPPL | 2012-09-18 |
| 14690 | SUPPL | 2012-09-18 |
| 4718 | SUPPL | 2012-09-18 |
| 14689 | SUPPL | 2010-08-19 |
| 4717 | SUPPL | 2010-08-16 |
| 21529 | SUPPL | 2008-02-19 |
| 23637 | ORIG | 2007-01-17 |
| 21528 | ORIG | 2004-06-14 |
| 27152 | SUPPL | 2004-01-14 |
| 4716 | SUPPL | 2003-06-08 |
| 4715 | SUPPL | 2002-10-09 |
| 14688 | ORIG | 2001-02-13 |
| 4714 | ORIG | 2001-02-13 |