Relieves inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. ANDA 75043, held by Sun Pharma Canada. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 75043 (Hydrocortisone Valerate), held by Sun Pharma Canada, was first approved by FDA on Aug 25, 1998, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrocortisone valerate cream, 0.2% and hydrocortisone valerate ointment, 0.2% are medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Valerate0.2% · ointment;topical | Hydrocortisone Valerate | Rx |
| Aug 4, 2003 | Supplement 5Labeling | Approved | None posted |
| Jul 29, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Apr 27, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Dec 21, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Aug 25, 1998 | 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
