Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 81271, held by Mission Pharma. Hydrocortisone.
As of Nov 14, 2026, ANDA 81271 (Texacort), held by Mission Pharma, was first approved by FDA on Apr 17, 1992, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrocortisone Topical Solution 2.5% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 17, 1992 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Texacort2.5% · solution;topical | Hydrocortisone | Rx |
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
