Treats relapsed or refractory acute lymphoblastic leukemia after at least two prior…. ANDA 208857, held by Amneal. Clofarabine.
As of Nov 15, 2026, ANDA 208857 (Clofarabine), held by Amneal, was first approved by FDA on Nov 6, 2017, with 0 approved supplements and 0 published complete response letters.
Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 6, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clofarabine20MG/20ML (1MG/ML) · solution;intravenous | Clofarabine | 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
