Treats chronic iron overload due to blood transfusions. ANDA 210060, held by Alembic. Deferasirox.
As of Nov 15, 2026, ANDA 210060 (Deferasirox), held by Alembic, was first approved by FDA on Nov 20, 2019, with 0 approved supplements and 0 published complete response letters.
Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2019 | Original application | Approved |
| Deferasirox125MG · tablet, for suspension;oral | Deferasirox | Rx |
| Deferasirox250MG · tablet, for suspension;oral | Deferasirox | Rx |
| Deferasirox500MG · tablet, for suspension;oral | Deferasirox | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
