Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 217671, held by Encube. Halcinonide.
As of Nov 13, 2026, ANDA 217671 (Halcinonide), held by Encube, was first approved by FDA on May 29, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Halcinonide Topical Solution, USP 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Halcinonide0.1% · solution;topical | Halcinonide | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
