Application 213465
- Type
- ANDA
- Sponsor
- PERRIGO UK FINCO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUMATRIPTAN | SUMATRIPTAN | SPRAY;NASAL | 20MG/SPRAY | No | No |
| 002 | SUMATRIPTAN | SUMATRIPTAN SUCCINATE | SPRAY;NASAL | 5MG/SPRAY | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-598 | SUMATRIPTAN | sumatriptan | Perrigo New York Inc | ANDA | Current |
| 45802-598 | SUMATRIPTAN | sumatriptan | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-598 | SUMATRIPTAN | sumatriptan | Perrigo New York Inc | ANDA | Current |
| 45802-619 | SUMATRIPTAN | sumatriptan | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 45802-619 | SUMATRIPTAN | sumatriptan | Perrigo New York Inc | ANDA | Current |
| 63629-8703 | SUMATRIPTAN | sumatriptan | Bryant Ranch Prepack | ANDA | Current |
| 63629-8703 | SUMATRIPTAN | sumatriptan | Bryant Ranch Prepack | ANDA | Current |
| 63629-8703 | SUMATRIPTAN | sumatriptan | Bryant Ranch Prepack | ANDA | Current |