Treats B-cell chronic lymphocytic leukemia (CLL). ANDA 220196, held by Hisun Pharm Hangzhou. Fludarabine Phosphate.
As of Nov 15, 2026, ANDA 220196 (Fludarabine Phosphate), held by Hisun Pharm Hangzhou, was first approved by FDA on Jul 23, 2026, with 0 approved supplements and 0 published complete response letters.
Fludarabine Phosphate Injection is indicated: as a component of a combination regimen for the treatment of adults with B-cell chronic lymphocytic leukemia (CLL); for the treatment of adults with B-cell CLL who have not responded to or whose disease has progressed during treatment with at least one alkylating-agent containing regimen.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludarabine Phosphate50MG/2ML (25MG/ML) · injectable;injection | Fludarabine Phosphate | 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
