ANDA 40884, held by Epic Pharma LLC. Phenytoin.
As of Nov 15, 2026, ANDA 40884 (Phenytoin), held by Epic Pharma LLC, was first approved by FDA on Nov 28, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 28, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phenytoin50MG ยท tablet, chewable;oral | Phenytoin | Rx |
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
