Treats B-cell chronic lymphocytic leukemia (CLL). ANDA 76661, held by Sagent Pharms Inc. Fludarabine Phosphate.
As of Nov 15, 2026, ANDA 76661 (Fludarabine Phosphate), held by Sagent Pharms Inc, was first approved by FDA on Apr 28, 2004, with 1 approved supplement and 0 published complete response letters.
Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult 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. Benefit in treatment-naïve or non-refractory CLL patients is not established. 1.1 Indication Fludarabine Phosphate Injection is indicated for the treatment of adult 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludarabine Phosphate50MG/2ML (25MG/ML) · injectable;injection | Fludarabine Phosphate | Rx |
| Jun 14, 2015 | Supplement 14Labeling | Approved | None posted |
| Apr 28, 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
