Treats B-cell chronic lymphocytic leukemia (CLL). ANDA 78393, held by Fresenius Kabi USA. Fludarabine Phosphate.
As of Nov 15, 2026, ANDA 78393 (Fludarabine Phosphate), held by Fresenius Kabi USA, was first approved by FDA on Oct 15, 2007, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fludarabine Phosphate Injection, USP is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate Injection, USP in previously untreated or non-refractory patients with CLL have not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2007 | 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
