ANDA 40503, held by Chartwell Molecular. Hydrocortisone.
As of Nov 13, 2026, ANDA 40503 (Hydrocortisone), held by Chartwell Molecular, was first approved by FDA on Mar 12, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone2.5% ยท cream;topical | Hydrocortisone | 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
