Application 079089
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BICALUTAMIDE | BICALUTAMIDE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65841-613 | Bicalutamide | Bicalutamide | Zydus Lifesciences Limited | ANDA | Current |
| 65841-613 | Bicalutamide | Bicalutamide | Cadila Healthcare Limited | ANDA | Current |
| 65841-613 | Bicalutamide | Bicalutamide | Cadila Healthcare Limited | ANDA | Current |
| 65841-613 | Bicalutamide | Bicalutamide | Cadila Healthcare Limited | ANDA | Current |
| 68382-224 | Bicalutamide | Bicalutamide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-224 | Bicalutamide | Bicalutamide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-224 | Bicalutamide | Bicalutamide | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-224 | Bicalutamide | Bicalutamide | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 18492 | ORIG | 2009-07-23 |
| 9221 | ORIG | 2009-07-09 |