Treats B-cell chronic lymphocytic leukemia (CLL). ANDA 90724, held by Areva Pharms. Fludarabine Phosphate.
As of Nov 15, 2026, ANDA 90724 (Fludarabine Phosphate), held by Areva Pharms, was first approved by FDA on Sep 27, 2010, with 4 approved supplements 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 |
|---|---|---|---|
| Sep 27, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludarabine Phosphate50MG/2ML (25MG/ML) · injectable;injection | Fludarabine Phosphate | Rx |
| Oct 26, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 26, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 26, 2026 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 29, 2023 | Supplement 6Manufacturing | Approved | |
| Sep 27, 2010 | 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
