ANDA 211395, held by Pharmobedient. Deferasirox.
As of Nov 15, 2026, ANDA 211395 (Deferasirox), held by Pharmobedient, was first approved by FDA on Mar 22, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2024 | Original application | Approved | None posted |
| Deferasirox90MG · tablet;oral | Deferasirox | Rx |
| Deferasirox180MG · tablet;oral | Deferasirox | Rx |
| Deferasirox360MG · tablet;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