ANDA 80828, held by Sciegen Pharms. Hydrocortisone Acetate.
As of Nov 15, 2026, ANDA 80828 (Hydrocortisone Acetate), held by Sciegen Pharms, was first approved by FDA on May 13, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 13, 1976 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Acetate0.5% ยท ointment;ophthalmic | Hydrocortisone Acetate | 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
