Treats chronic iron overload due to blood transfusions. ANDA 214474, held by Aurobindo Pharma Ltd. Deferasirox.
As of Nov 15, 2026, ANDA 214474 (Deferasirox), held by Aurobindo Pharma Ltd, was first approved by FDA on Oct 16, 2023, with 0 approved supplements and 0 published complete response letters.
Deferasirox tablets 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 |
|---|---|---|---|
| Oct 16, 2023 | Original application | Approved | None posted |
| Deferasirox90MG · tablet;oral | Deferasirox | Rx |
| Deferasirox180MG · tablet;oral | Deferasirox | Rx |
| Deferasirox360MG · tablet;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
