Relieves inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses. ANDA 203810, held by Encube. Hydrocortisone.
As of Nov 13, 2026, ANDA 203810 (Hydrocortisone), held by Encube, was first approved by FDA on Jul 23, 2018, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE SECTION Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone2.5% · cream;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
