Treats transfusional iron overload. ANDA 208800, held by Taro. Deferiprone.
As of Nov 14, 2026, ANDA 208800 (Deferiprone), held by Taro, was first approved by FDA on Feb 8, 2019, with 2 approved supplements and 0 published complete response letters.
Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 8, 2019 | Original application | Approved |
| Deferiprone500MG · tablet;oral | Deferiprone | Rx |
| Deferiprone1GM · tablet;oral | Deferiprone | Rx |
| Dec 14, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 14, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 8, 2019 | Original application | Approved |
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
