Fosphenytoin Sodium

Controls generalized tonic-clonic status epilepticus and prevention and treatment of…. ANDA 78476, held by Amneal. Fosphenytoin Sodium.

As of Nov 15, 2026, ANDA 78476 (Fosphenytoin Sodium), held by Amneal, was first approved by FDA on Mar 18, 2008, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 18, 2008
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Fosphenytoin sodium injection, USP is indicated for the control of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin can also be substituted, short-term, for oral phenytoin. Fosphenytoin should be used only when oral phenytoin administration is not possible. Fosphenytoin must not be given orally.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 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	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Aug 24, 2022	Supplement 16Labeling · Standard review	Approved	None posted
Aug 24, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Feb 17, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Oct 21, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Oct 21, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Oct 21, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Oct 21, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Oct 15, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Apr 15, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Apr 15, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Apr 15, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Apr 15, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Mar 18, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78476
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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