ANDA 84492, held by Epic Pharma LLC. Prednisolone Acetate.
As of Nov 15, 2026, ANDA 84492 (Prednisolone Acetate), held by Epic Pharma LLC, was first approved by FDA on Jun 12, 1975, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone Acetate50MG/ML ยท injectable;injection | Prednisolone 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
