ANDA 85733, held by Ivax Pharms. Hydrocortisone.
As of Nov 13, 2026, ANDA 85733 (Hydrocortisone), held by Ivax Pharms, was first approved by FDA on Nov 6, 1978, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 6, 1978 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone1% 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
