ANDA 87315, held by Alpharma US Pharms. Hydrocortisone.
As of Nov 13, 2026, ANDA 87315 (Hydrocortisone), held by Alpharma US Pharms, was first approved by FDA on Jun 7, 1982, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrocortisone1% ยท lotion;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
