ANDA 214194, held by Amneal. Deferasirox.
As of Nov 15, 2026, ANDA 214194 (Deferasirox), held by Amneal, was first approved by FDA on Feb 9, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 2021 | Original application | Approved | None posted |
| Deferasirox180MG · granule;oral | Deferasirox | Discontinued |
| Deferasirox360MG · granule;oral | Deferasirox | Discontinued |
| Deferasirox90MG · granule;oral | Deferasirox | Discontinued |
| Aug 2, 2021 | Supplement 1Manufacturing | Approved | None posted |
| Feb 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
