Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 40879, held by Rising. Hydrocortisone.
As of Nov 14, 2026, ANDA 40879 (Hydrocortisone), held by Rising, was first approved by FDA on Aug 20, 2010, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2010 | 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
