Treats actinic keratosis lesions of the face, ears, and/or scalp. NDA 22259, held by Hill Dermaceuticals. Fluorouracil.
As of Nov 13, 2026, NDA 22259 (Tolak), held by Hill Dermaceuticals, was first approved by FDA on Sep 18, 2015, with 1 approved supplement and 0 published complete response letters.
Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tolak4% · cream;topical | Fluorouracil | RxReference drug |
| Aug 25, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Sep 18, 2015 | Original applicationNew formulation or manufacturer · Standard review | 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
