Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 88799, held by Taro. Hydrocortisone.
As of Nov 14, 2026, ANDA 88799 (Hydrocortisone), held by Taro, was first approved by FDA on Nov 9, 1984, with 14 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 |
|---|---|---|---|
| Nov 9, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone2.5% · cream;topical | Hydrocortisone | Rx |
| Jul 28, 2005 | Supplement 27Labeling | Approved | None posted |
| Apr 28, 2005 | Supplement 30Labeling | Approved | None posted |
| Apr 29, 1993 | Supplement 25Labeling | Approved | None posted |
| Nov 16, 1992 | Supplement 16Labeling | Approved | None posted |
| Feb 21, 1992 | Supplement 14Labeling | Approved | None posted |
| Dec 17, 1990 | Supplement 13Labeling | Approved | None posted |
| Mar 28, 1990 | Supplement 6Manufacturing | Approved | None posted |
| Mar 28, 1990 | Supplement 9Manufacturing | Approved | None posted |
| Jul 13, 1989 | Supplement 11Manufacturing | Approved | None posted |
| Jul 13, 1989 | Supplement 12Manufacturing | Approved | None posted |
| May 5, 1989 | Supplement 10Labeling | Approved | None posted |
| Jul 24, 1986 | Supplement 4Manufacturing | Approved | None posted |
| Dec 6, 1985 | Supplement 2Manufacturing | Approved | None posted |
| Apr 3, 1985 | Supplement 1Manufacturing | Approved | None posted |
| Nov 9, 1984 | 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
