Application 212462
- Type
- ANDA
- Sponsor
- QILU
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ABIRATERONE ACETATE | ABIRATERONE ACETATE | TABLET;ORAL | 250MG | No | No |
| 002 | ABIRATERONE ACETATE | ABIRATERONE ACETATE | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-4764 | abiraterone acetate | Abiraterone acetate | Apotex Corp. | ANDA | Current |
| 60505-4764 | abiraterone acetate | Abiraterone acetate | Apotex Corp. | ANDA | Current |
| 71921-178 | abiraterone acetate | abiraterone acetate | Florida Pharmaceutical Products, LLC. | ANDA | Current |
| 72606-566 | Abiraterone acetate | Abiraterone acetate | CELLTRION USA, INC. | ANDA | Current |
| 72606-566 | Abiraterone acetate | Abiraterone acetate | CELLTRION USA, INC. | ANDA | Current |
| 72606-566 | Abiraterone acetate | Abiraterone acetate | CELLTRION USA, INC. | ANDA | Current |
| 72606-566 | Abiraterone acetate | Abiraterone acetate | CELLTRION USA, INC. | ANDA | Current |
| 72606-573 | Abiraterone acetate | Abiraterone acetate | CELLTRION USA, INC. | ANDA | Current |
| 72606-573 | Abiraterone acetate | Abiraterone acetate | CELLTRION USA, INC. | ANDA | Current |