ANDA 86050, held by Purepac Pharm. Hydrocortisone Acetate.
As of Nov 15, 2026, ANDA 86050 (Hydrocortisone Acetate), held by Purepac Pharm, was not approved, with 1 approved supplement and 0 published complete response letters.
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone Acetate0.5% ยท cream;topical | Hydrocortisone Acetate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 1982 | Supplement 2Manufacturing | Approved | None posted |
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
