Treats multiple actinic or solar keratoses. ANDA 77524, held by Dr Reddys Labs SA. Fluorouracil.
As of Nov 15, 2026, ANDA 77524 (Fluorouracil), held by Dr Reddys Labs SA, was first approved by FDA on Apr 11, 2008, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fluorouracil Cream 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 |
|---|---|---|---|
| Apr 11, 2008 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluorouracil5% · cream;topical | Fluorouracil | Rx |
| Sep 30, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 29, 2014 | Supplement 2Labeling | Approved | None posted |
| Apr 11, 2008 | 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
