Application 210920
- Type
- ANDA
- Sponsor
- BIONPHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 125MG | No | No |
| 002 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 250MG | No | No |
| 003 | DEFERASIROX | DEFERASIROX | TABLET, FOR SUSPENSION;ORAL | 500MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69452-159 | Deferasirox | Deferasirox | Bionpharma Inc. | ANDA | Current |
| 69452-159 | Deferasirox | deferasirox | Bionpharma Inc. | ANDA | Current |
| 69452-159 | Deferasirox | deferasirox | Bionpharma Inc. | ANDA | Current |
| 69452-160 | Deferasirox | Deferasirox | Bionpharma Inc. | ANDA | Current |
| 69452-160 | Deferasirox | deferasirox | Bionpharma Inc. | ANDA | Current |
| 69452-160 | Deferasirox | deferasirox | Bionpharma Inc. | ANDA | Current |
| 69452-161 | Deferasirox | Deferasirox | Bionpharma Inc. | ANDA | Current |
| 69452-161 | Deferasirox | deferasirox | Bionpharma Inc. | ANDA | Current |
| 69452-161 | Deferasirox | deferasirox | Bionpharma Inc. | ANDA | Current |