ANDA 78277, held by Am Regent. Fosphenytoin Sodium.
As of Nov 15, 2026, ANDA 78277 (Fosphenytoin Sodium), held by Am Regent, was first approved by FDA on Aug 6, 2007, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fosphenytoin SodiumEQ 50MG PHENYTOIN NA/ML · injectable;injection | Fosphenytoin Sodium | Discontinued |
| Jun 24, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 19, 2013 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 6, 2007 | Original application | Approved |
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
