ANDA 40398, held by Legacy. Hydrocortisone Acetate.
As of Nov 15, 2026, ANDA 40398 (Micort-Hc), held by Legacy, was first approved by FDA on Mar 29, 2002, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Micort-Hc2% ยท cream;topical | Hydrocortisone Acetate | Discontinued |
| Mar 30, 2009 | Supplement 4Labeling | Approved | None posted |
| Mar 29, 2002 | 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
