ANDA 210856, held by Hisun Pharm Hangzhou. Cladribine.
As of Nov 14, 2026, ANDA 210856 (Cladribine), held by Hisun Pharm Hangzhou, was first approved by FDA on Nov 25, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS FOR USE 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 |
|---|---|---|---|
| Nov 25, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cladribine1MG/ML · injectable;injection | Cladribine | 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
