Application 204519
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS 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 |
|---|
| 13811-658 | Celecoxib | Celecoxib | Trigen Laboratories, LLC | ANDA | Current |
| 13811-659 | Celecoxib | Celecoxib | Trigen Laboratories, LLC | ANDA | Current |
| 13811-660 | Celecoxib | Celecoxib | Trigen Laboratories, LLC | ANDA | Current |
| 13811-661 | Celecoxib | Celecoxib | Trigen Laboratories, LLC | ANDA | Current |
| 45865-943 | Celecoxib | Celecoxib | medsource pharmaceuticals | ANDA | Current |
| 46708-267 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-267 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-268 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-268 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-269 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-269 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-270 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-270 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Limited | ANDA | Current |
| 50268-168 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-168 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-168 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-168 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-169 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-169 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-169 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 50268-169 | Celecoxib | Celecoxib | AvPAK | ANDA | Current |
| 53002-1338 | Celecoxib | Celecoxib | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1338 | Celecoxib | Celecoxib | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-206 | Celecoxib 200 mg | CELECOXIB | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 59088-723 | CeleXib 100-EZS | Celecoxib | PureTek Corporation | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-140 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-141 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-142 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-143 | Celecoxib | Celecoxib | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 63187-633 | Celecoxib 200 mg | CELECOXIB | Proficient Rx LP | ANDA | Current |
| 63187-633 | Celecoxib 200 mg | CELECOXIB | Proficient Rx LP | ANDA | Current |
| 67296-1600 | Celecoxib | Celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1600 | Celecoxib | Celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1600 | Celecoxib | Celecoxib | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4476 | Celecoxib | Celecoxib | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4476 | Celecoxib | Celecoxib | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8969 | Celecoxib 200 mg | CELECOXIB | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69399-182 | Celecoxib 50 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 69399-183 | Celecoxib 100 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 69399-184 | Celecoxib 200 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 69399-185 | Celecoxib 400 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 69399-194 | Celecoxib 200 mg | CELECOXIB | SYDON LABS LLC | ANDA | Current |
| 71205-020 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-020 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-055 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 71205-055 | Celecoxib | Celecoxib | Proficient Rx LP | ANDA | Current |
| 80175-0142 | celecoxib | celecoxib | Central Packaging | ANDA | Current |
| 80175-0142 | celecoxib | celecoxib | Central Packaging | ANDA | Current |