Treats chronic iron overload due to blood transfusions. ANDA 214559, held by Pharmazone. Deferasirox.
As of Nov 15, 2026, ANDA 214559 (Deferasirox), held by Pharmazone, was first approved by FDA on Mar 9, 2021, with 1 approved supplement and 0 published complete response letters.
Deferasirox oral granules is 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 9, 2021 | Original application | Approved | None posted |
| Deferasirox90MG · granule;oral | Deferasirox | Rx |
| Deferasirox180MG · granule;oral | Deferasirox | Rx |
| Deferasirox360MG · granule;oral | Deferasirox | Rx |
| Apr 28, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 9, 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
