ANDA 75666, held by Padagis Israel. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 75666 (Hydrocortisone Valerate), held by Padagis Israel, was first approved by FDA on May 24, 2000, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Valerate0.2% ยท cream;topical | Hydrocortisone Valerate | Discontinued |
| May 18, 2004 | Supplement 1Labeling | Approved | None posted |
| May 24, 2000 | 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
