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Application 090374
- Type
- ANDA
- Sponsor
- ORCHID HLTHCARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZALEPLON | ZALEPLON | CAPSULE;ORAL | 5MG | No | No |
| 002 | ZALEPLON | ZALEPLON | CAPSULE;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42043-210 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-210 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-210 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-210 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-210 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-211 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-211 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-211 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-211 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 42043-211 | Zaleplon | Zaleplon | OrchidPharma Inc | ANDA | Current |
| 71335-1387 | Zaleplon | Zaleplon | Bryant Ranch Prepack | ANDA | Current |
| 71335-1387 | Zaleplon | Zaleplon | Bryant Ranch Prepack | ANDA | Current |
| 71335-1466 | Zaleplon | Zaleplon | Bryant Ranch Prepack | ANDA | Current |
| 71335-1466 | Zaleplon | Zaleplon | Bryant Ranch Prepack | ANDA | Current |