ANDA 83738, held by Bel Mar. Prednisolone Acetate.
As of Nov 15, 2026, ANDA 83738 (Prednisolone Acetate), held by Bel Mar, was first approved by FDA on Mar 6, 1974, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 1974 | Original application | Approved | None posted |
| Prednisolone Acetate25MG/ML · injectable;injection | Prednisolone Acetate | Discontinued |
| Prednisolone Acetate50MG/ML · 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
