ANDA 200648, held by Rising. Fludarabine Phosphate.
As of Nov 15, 2026, ANDA 200648 (Fludarabine Phosphate), held by Rising, was first approved by FDA on Oct 16, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludarabine Phosphate50MG/VIAL ยท injectable;injection | Fludarabine Phosphate | Discontinued |
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
