ANDA 78544, held by Fresenius Kabi USA. Fludarabine Phosphate.
As of Nov 15, 2026, ANDA 78544 (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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fludarabine Phosphate50MG/VIAL ยท 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
