Application 212469
- Type
- ANDA
- Sponsor
- PADAGIS ISRAEL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLMITRIPTAN | ZOLMITRIPTAN | SPRAY;NASAL | 2.5MG/SPRAY | No | No |
| 002 | ZOLMITRIPTAN | ZOLMITRIPTAN | SPRAY;NASAL | 5MG/SPRAY | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-711 | zolmitriptan | zolmitriptan | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 63629-9575 | zolmitriptan | zolmitriptan | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68921 | ORIG | 2021-10-08 |