ANDA 83759, held by Watson Labs. Hydrocortisone Acetate.
As of Nov 15, 2026, ANDA 83759 (Hydrocortisone Acetate), held by Watson Labs, was not approved, with 0 approved supplements and 0 published complete response letters.
| 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
