Treats chronic iron overload due to blood transfusions. ANDA 215026, held by Cipla. Deferasirox.
As of Nov 15, 2026, ANDA 215026 (Deferasirox), held by Cipla, was first approved by FDA on Feb 23, 2022, with 0 approved supplements and 0 published complete response letters.
Deferasirox granule 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 |
|---|---|---|---|
| Feb 23, 2022 | Original application | Approved | None posted |
| Deferasirox90MG · granule;oral | Deferasirox | Rx |
| Deferasirox180MG · granule;oral | Deferasirox | Rx |
| Deferasirox360MG · granule;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
