Treats B-cell chronic lymphocytic leukemia (CLL). ANDA 78610, held by Actavis Totowa. Fludarabine Phosphate.
As of Nov 15, 2026, ANDA 78610 (Fludarabine Phosphate), held by Actavis Totowa, was first approved by FDA on Feb 11, 2009, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fludarabine Phosphate for 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. The safety and effectiveness of Fludarabine Phosphate for Injection in previously untreated or non-refractory patients with CLL have not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 11, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludarabine Phosphate50MG/VIAL · injectable;injection | Fludarabine Phosphate | Rx |
| Sep 7, 2011 | Supplement 3Labeling | Approved | None posted |
| May 24, 2010 | Supplement 1Labeling | Approved | None posted |
| Feb 11, 2009 | 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
