ANDA 89495, held by Beta Dermac. Hydrocortisone.
As of Nov 14, 2026, ANDA 89495 (Beta-Hc), held by Beta Dermac, was first approved by FDA on Jan 25, 1988, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 1988 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Beta-Hc1% 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