Application 208697
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DEFERASIROX | DEFERASIROX | TABLET;ORAL | 90MG | No | No |
| 002 | DEFERASIROX | DEFERASIROX | TABLET;ORAL | 180MG | No | No |
| 003 | DEFERASIROX | DEFERASIROX | TABLET;ORAL | 360MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-3853 | Deferasirox | Deferasirox | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3853 | Deferasirox | Deferasirox | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3853 | Deferasirox | Deferasirox | Actavis Pharma, Inc. | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 62172 | ORIG | 2020-03-17 |