ANDA 85677, held by Watson Labs. Cortisone Acetate.
As of Nov 15, 2026, ANDA 85677 (Cortisone Acetate), held by Watson Labs, was first approved by FDA on Mar 7, 1978, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 1978 | Original application | Approved | None posted |
| Cortisone Acetate25MG/ML · injectable;injection | Cortisone Acetate | Discontinued |
| Cortisone Acetate50MG/ML · injectable;injection | Cortisone 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