Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 89074, held by Padagis US. Hydrocortisone.
As of Nov 13, 2026, ANDA 89074 (Stie-Cort), held by Padagis US, was first approved by FDA on Nov 26, 1985, with 12 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 26, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Stie-Cort2.5% · lotion;topical | Hydrocortisone | Rx |
| Nov 28, 2007 | Supplement 15Labeling | Approved | None posted |
| Aug 16, 2001 | Supplement 14Manufacturing | Approved | None posted |
| Aug 3, 1998 | Supplement 13Manufacturing | Approved | None posted |
| Jan 17, 1996 | Supplement 10Manufacturing | Approved | None posted |
| Jan 17, 1996 | Supplement 9Labeling | Approved | None posted |
| Sep 14, 1995 | Supplement 12Manufacturing | Approved | None posted |
| Sep 14, 1995 | Supplement 7Manufacturing | Approved | None posted |
| Sep 14, 1995 | Supplement 8Labeling | Approved | None posted |
| Apr 14, 1995 | Supplement 11Manufacturing | Approved | None posted |
| May 14, 1986 | Supplement 1Manufacturing | Approved | None posted |
| May 14, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Apr 11, 1986 | Supplement 4Manufacturing | Approved | None posted |
| Nov 26, 1985 | 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
