ANDA 211129, held by Glenmark Pharms Ltd. Hydrocortisone Valerate.
As of Nov 15, 2026, ANDA 211129 (Hydrocortisone Valerate), held by Glenmark Pharms Ltd, was first approved by FDA on Oct 12, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 12, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Valerate0.2% ยท cream;topical | Hydrocortisone Valerate | Discontinued |
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
