Treats chronic iron overload due to blood transfusions. ANDA 214650, held by Msn. Deferasirox.
As of Nov 15, 2026, ANDA 214650 (Deferasirox), held by Msn, was first approved by FDA on Mar 17, 2021, with 1 approved supplement and 0 published complete response letters.
Deferasirox oral granules 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 |
|---|---|---|---|
| Mar 17, 2021 | Original application | Approved | None posted |
| Deferasirox180MG · granule;oral | Deferasirox | Rx |
| Deferasirox360MG · granule;oral | Deferasirox | Rx |
| Deferasirox90MG · granule;oral | Deferasirox | Rx |
| Oct 23, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 17, 2021 | Original application | Approved | None posted |
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
