Application 200562
- Type
- ANDA
- Sponsor
- WATSON LABS INC
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-3982 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3982 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3982 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3982 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3982 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3983 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3983 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3983 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3983 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3983 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3984 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3984 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3984 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3984 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3984 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3985 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3985 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3985 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3985 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3985 | Celecoxib | Celecoxib | Actavis Pharma, Inc. | ANDA | Current |
| 50436-3983 | Celecoxib | Celecoxib | Unit Dose Services | ANDA | Current |
| 50436-3983 | Celecoxib | Celecoxib | Unit Dose Services | ANDA | Current |
| 50436-3984 | Celecoxib | Celecoxib | Unit Dose Services | ANDA | Current |
| 50436-3984 | Celecoxib | Celecoxib | Unit Dose Services | ANDA | Current |
| 55700-337 | Celecoxib | Celecoxib | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63187-643 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 63187-643 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 63187-643 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 63187-643 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 68788-8936 | Celecoxib | Celecoxib | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71335-0597 | Celecoxib | Celecoxib | Bryant Ranch Prepack | ANDA | Current |