Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 80692, held by Fougera Pharms. Hydrocortisone.
As of Nov 13, 2026, ANDA 80692 (Hydrocortisone), held by Fougera Pharms, was first approved by FDA on Apr 16, 1975, with 11 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 |
|---|---|---|---|
| Apr 16, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone1% · ointment;topical | Hydrocortisone | RxReference drug |
| Mar 7, 1996 | Supplement 26Manufacturing | Approved | None posted |
| Nov 8, 1995 | Supplement 25Manufacturing | Approved | None posted |
| Aug 7, 1995 | Supplement 24Manufacturing | Approved | None posted |
| Jul 30, 1987 | Supplement 22Manufacturing | Approved | None posted |
| Jan 26, 1984 | Supplement 20Manufacturing | Approved | None posted |
| Jul 13, 1982 | Supplement 8Manufacturing | Approved | None posted |
| Jul 13, 1982 | Supplement 9Manufacturing | Approved | None posted |
| Jul 13, 1982 | Supplement 12Manufacturing | Approved | None posted |
| Jul 13, 1982 | Supplement 13Manufacturing | Approved | None posted |
| Jul 13, 1982 | Supplement 14Manufacturing | Approved | None posted |
| Jul 13, 1982 | Supplement 15Manufacturing | Approved | None posted |
| Apr 16, 1975 | Original application | Approved | None posted |
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
