ANDA 83739, held by Bel Mar. Hydrocortisone Acetate.
As of Nov 15, 2026, ANDA 83739 (Hydrocortisone Acetate), held by Bel Mar, was first approved by FDA on Jan 21, 1974, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 21, 1974 | Original application | Approved | None posted |
| Hydrocortisone Acetate25MG/ML · injectable;injection | Hydrocortisone Acetate | Discontinued |
| Hydrocortisone Acetate50MG/ML · injectable;injection | Hydrocortisone Acetate | 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
