ANDA 87791, held by Marchar. Fluorouracil.
As of Nov 14, 2026, ANDA 87791 (Fluorouracil), held by Marchar, was first approved by FDA on Jan 18, 1983, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorouracil50MG/ML ยท 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
