Treats chronic iron overload due to blood transfusions. ANDA 209878, held by Msn. Deferasirox.
As of Nov 15, 2026, ANDA 209878 (Deferasirox), held by Msn, was first approved by FDA on Nov 20, 2019, with 2 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 |
| Mar 7, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 7, 2025 | Supplement 6Labeling · 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
