ANDA 80630, held by Ivax Sub Teva Pharms. Cortisone Acetate.
As of Nov 15, 2026, ANDA 80630 (Cortisone Acetate), held by Ivax Sub Teva Pharms, was first approved by FDA on Jan 3, 1972, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 3, 1972 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cortisone Acetate25MG ยท tablet;oral | 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
