ANDA 215699, held by Kindos. Fluorouracil.
As of Nov 14, 2026, ANDA 215699 (Fluorouracil), held by Kindos, was first approved by FDA on Feb 6, 2025, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 6, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorouracil5GM/100ML (50MG/ML) · injectable;injection | Fluorouracil | Rx |
| Feb 5, 2026 | Supplement 5Labeling · Standard review | Approved | |
| Feb 6, 2025 | Original application | Approved | None posted |
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
