ANDA 88041, held by Solvay. Hydrocortisone.
As of Nov 13, 2026, ANDA 88041 (Balneol-Hc), held by Solvay, was first approved by FDA on Dec 3, 1982, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 3, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Balneol-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
