ANDA 78158, held by Hospira. Fosphenytoin Sodium.
As of Nov 15, 2026, ANDA 78158 (Fosphenytoin Sodium), held by Hospira, was first approved by FDA on Aug 6, 2007, with 0 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 ยท injectable;injection | Fosphenytoin Sodium | 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
