ANDA 40333, held by Teva Pharms USA. Fluorouracil.
As of Nov 14, 2026, ANDA 40333 (Fluorouracil), held by Teva Pharms USA, was first approved by FDA on Jan 27, 2000, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorouracil500MG/10ML (50MG/ML) · injectable;injection | Fluorouracil | Discontinued |
| Feb 10, 2026 | Supplement 34Labeling · Standard review | Approved | |
| Mar 21, 2024 | Supplement 33Labeling · Standard review | Approved | |
| Dec 27, 2016 | Supplement 30Labeling · Standard review | Approved | None posted |
| Jan 27, 2000 | Original application | Approved |
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
