Application 210628
- Type
- ANDA
- Sponsor
- UMEDICA LABS PVT LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 50MG | No | No |
| 002 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 100MG | No | No |
| 003 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 200MG | No | No |
| 004 | CELECOXIB | CELECOXIB | CAPSULE;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60290-016 | CELECOXIB | CELECOXIB | UMEDICA LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 60290-016 | CELECOXIB | CELECOXIB | UMEDICA LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 60290-017 | CELECOXIB | CELECOXIB | UMEDICA LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 60290-017 | CELECOXIB | CELECOXIB | UMEDICA LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 60290-018 | CELECOXIB | CELECOXIB | UMEDICA LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 60290-018 | CELECOXIB | CELECOXIB | UMEDICA LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 60290-019 | CELECOXIB | CELECOXIB | UMEDICA LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 60290-019 | CELECOXIB | CELECOXIB | UMEDICA LABORATORIES PRIVATE LIMITED | ANDA | Current |
| 68071-2626 | CELECOXIB | CELECOXIB | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-3292 | CELECOXIB | CELECOXIB | REMEDYREPACK INC. | ANDA | Current |
| 70518-3292 | CELECOXIB | CELECOXIB | REMEDYREPACK INC. | ANDA | Current |
| 70518-3424 | CELECOXIB | CELECOXIB | REMEDYREPACK INC. | ANDA | Current |
| 71335-2019 | CELECOXIB | CELECOXIB | Bryant Ranch Prepack | ANDA | Current |
| 71335-2019 | CELECOXIB | CELECOXIB | Bryant Ranch Prepack | ANDA | Current |
| 75834-236 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-236 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-236 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-236 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-236 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-236 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-237 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-237 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-237 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-237 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-237 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-237 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-238 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-238 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-238 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-238 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-238 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-238 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-239 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-239 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-239 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-239 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-239 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |
| 75834-239 | CELECOXIB | CELECOXIB | NIVAGEN PHARMACEUTICALS, INC. | ANDA | Current |