Cerebyx

NDA 20450, held by Parke Davis. Fosphenytoin Sodium.

As of Nov 13, 2026, NDA 20450 (Cerebyx), held by Parke Davis, was first approved by FDA on Aug 5, 1996, with 29 approved supplements and 0 published complete response letters.

First approved: Aug 5, 1996
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Mar 1, 2017	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Aug 5, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
CerebyxEQ 50MG PHENYTOIN NA/ML · injectable;injection	Fosphenytoin Sodium	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Apr 28, 2022	Supplement 46Labeling · Standard review	Approved	Label
Dec 2, 2021	Supplement 45Labeling · Standard review	Approved	Label Letter
Feb 16, 2021	Supplement 42Labeling · Standard review	Approved	Label Letter
Jan 28, 2020	Supplement 40Labeling · Standard review	Approved	Letter Label
Jul 12, 2019	Supplement 39Labeling · Standard review	Approved	Label Letter
Oct 31, 2017	Supplement 38Labeling · Standard review	Approved	Letter Label
Oct 31, 2017	Supplement 37Labeling · Standard review	Approved	Letter Label
Mar 10, 2017	Supplement 36Labeling · Standard review	Approved	Label Letter
Mar 1, 2017	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Nov 4, 2016	Supplement 33Labeling · Standard review	Approved	Letter Label
Jun 16, 2016	Supplement 31Labeling · Standard review	Approved	Label
Jun 1, 2016	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 3, 2016	Supplement 29Labeling · Standard review	Approved	Letter Label
Jun 4, 2015	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 12, 2014	Supplement 25Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 3, 2014	Supplement 23Labeling · Standard review	Approved	Label Letter
Oct 22, 2013	Supplement 24Labeling · Standard review	Approved	Label Letter
Aug 30, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Mar 6, 2013	Supplement 20Labeling · Standard review	Approved	Letter Label
Nov 13, 2011	Supplement 19Labeling	Approved	Letter Label
Nov 13, 2011	Supplement 16Labeling · Standard review	Approved	Letter Label
Nov 13, 2011	Supplement 9Labeling · Standard review	Approved	Letter Label
Nov 13, 2011	Supplement 8Labeling · Standard review	Approved	Letter Label
Jan 2, 2002	Supplement 7Labeling · Standard review	Approved	None posted
Aug 13, 2001	Supplement 5Labeling · Standard review	Approved	Review Label
Aug 13, 2001	Supplement 4Labeling · Standard review	Approved	Review Label
Nov 20, 1998	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 26, 1996	Supplement 1Labeling · Standard review	Approved	Review
Aug 5, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20450
Drugs@FDA: Overview at FDA
Company: Parke-Davis

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