Treats chronic iron overload due to blood transfusions. ANDA 207124, held by Teva Pharms USA. Deferasirox.
As of Nov 15, 2026, ANDA 207124 (Deferasirox), held by Teva Pharms USA, was first approved by FDA on Sep 23, 2022, 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 |
|---|---|---|---|
| Sep 23, 2022 | Original application | Approved | None posted |
| 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
