Treats chronic iron overload due to blood transfusions. ANDA 210519, held by Alkem Labs Ltd. Deferasirox.
As of Nov 15, 2026, ANDA 210519 (Deferasirox), held by Alkem Labs Ltd, was first approved by FDA on Nov 20, 2019, with 1 approved supplement 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 |
| Nov 18, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 20, 2019 | Original application | Approved |
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
