ANDA 76401, held by Fresenius Kabi USA. Vincristine Sulfate.
As of Nov 15, 2026, ANDA 76401 (Vincristine Sulfate), held by Fresenius Kabi USA, was first approved by FDA on Oct 28, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vincristine Sulfate1MG/ML ยท injectable;injection | Vincristine Sulfate | 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
