ANDA 78137, held by Wockhardt Bio AG. Fosphenytoin Sodium.
As of Nov 15, 2026, ANDA 78137 (Fosphenytoin Sodium), held by Wockhardt Bio AG, 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 | 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
