ANDA 91299, held by Sandoz. Fluorouracil.
As of Nov 15, 2026, ANDA 91299 (Fluorouracil), held by Sandoz, was first approved by FDA on May 2, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 2011 | Original application | Approved | None posted |
| Fluorouracil2.5GM/50ML (50MG/ML) · injectable;injection | Fluorouracil | Discontinued |
| Fluorouracil5GM/100ML (50MG/ML) · injectable;injection | Fluorouracil | 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
