ANDA 40364, held by Nesher Pharms. Prednisolone.
As of Nov 15, 2026, ANDA 40364 (Prednisolone), held by Nesher Pharms, was first approved by FDA on Apr 10, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 10, 2002 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone15MG/5ML ยท solution;oral | Prednisolone | 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
