Fosphenytoin Sodium

ANDA 78417, held by Sun Pharm. Fosphenytoin Sodium.

As of Nov 15, 2026, ANDA 78417 (Fosphenytoin Sodium), held by Sun Pharm, was first approved by FDA on Mar 18, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 18, 2008
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 18, 2008	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Aug 21, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Mar 18, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78417
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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