ANDA 76571, held by Fresenius Kabi USA. Cladribine.
As of Nov 14, 2026, ANDA 76571 (Cladribine), held by Fresenius Kabi USA, was first approved by FDA on Apr 22, 2004, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE: Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cladribine1MG/ML · injectable;injection | Cladribine | Rx |
| Sep 29, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 22, 2004 | 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
