Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 40396, held by Legacy. Hydrocortisone Acetate.
As of Nov 15, 2026, ANDA 40396 (Micort-Hc), held by Legacy, was first approved by FDA on Feb 27, 2001, with 1 approved supplement 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 |
|---|---|---|---|
| Feb 27, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Micort-Hc2.5% · cream;topical | Hydrocortisone Acetate | Rx |
| Jun 28, 2012 | Supplement 2Manufacturing | Approved | None posted |
| Feb 27, 2001 | Original application | 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
