Treats multiple actinic or solar keratoses. ANDA 214845, held by Accord Hlthcare. Fluorouracil.
As of Nov 14, 2026, ANDA 214845 (Fluorouracil), held by Accord Hlthcare, was first approved by FDA on Oct 7, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE: Fluorouracil Cream USP is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 7, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorouracil5% · cream;topical | Fluorouracil | Rx |
| Sep 22, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 7, 2021 | 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
