Fosphenytoin Sodium

ANDA 78736, held by Pharmobedient. Fosphenytoin Sodium.

As of Nov 15, 2026, ANDA 78736 (Fosphenytoin Sodium), held by Pharmobedient, was first approved by FDA on Jun 8, 2010, with 8 approved supplements and 0 published complete response letters.

First approved: Jun 8, 2010
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jun 8, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fosphenytoin SodiumEQ 50MG PHENYTOIN NA/ML · injectable;injection	Fosphenytoin Sodium	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Nov 28, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Nov 28, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Dec 23, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Nov 6, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Nov 6, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 9, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Jun 24, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Aug 16, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Jun 8, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78736
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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