Dilantin

NDA 10151, held by Parke Davis. Phenytoin Sodium.

As of Nov 13, 2026, NDA 10151 (Dilantin), held by Parke Davis, was first approved by FDA on Mar 1, 1956, with 32 approved supplements and 0 published complete response letters.

First approved: Mar 1, 1956
Review: Standard
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Mar 1, 1956	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dilantin50MG/ML · injectable;injection	Phenytoin Sodium	Discontinued

All 33 submissions, including labeling and manufacturing supplements


Oct 31, 2017	Supplement 47Labeling · Standard review	Approved	Label
Oct 31, 2017	Supplement 48Labeling · Standard review	Approved	Label
Aug 15, 2017	Supplement 46Labeling · Standard review	Approved	Letter Label
Nov 30, 2016	Supplement 45Labeling · Standard review	Approved	Letter
Nov 30, 2016	Supplement 44Labeling · Standard review	Approved	Letter
Jun 16, 2016	Supplement 42Labeling · Standard review	Approved	Label
Jan 25, 2016	Supplement 41Labeling · Standard review	Approved	Letter Label
Apr 15, 2015	Supplement 40Labeling · Standard review	Approved	Letter Label
Apr 3, 2014	Supplement 39Labeling · Standard review	Approved	Label Letter
Jan 24, 2014	Supplement 38Labeling · Standard review	Approved	Letter Label
Mar 6, 2013	Supplement 37Labeling · Standard review	Approved	Letter Label
Nov 13, 2011	Supplement 36Labeling · Standard review	Approved	Letter Label
Nov 20, 2001	Supplement 34Labeling · Standard review	Approved	Review Letter
Nov 20, 2001	Supplement 33Labeling · Standard review	Approved	Review Letter
Nov 20, 2001	Supplement 32Labeling · Standard review	Approved	Review Letter
Nov 20, 2001	Supplement 30Labeling	Approved	Review Letter
Nov 20, 2001	Supplement 29Labeling	Approved	Review Letter
Nov 20, 2001	Supplement 22Labeling	Approved	Review Letter
May 30, 1997	Supplement 35Manufacturing · Standard review	Approved	None posted
Nov 22, 1995	Supplement 31Labeling · Standard review	Approved	None posted
Sep 30, 1986	Supplement 28Manufacturing · Standard review	Approved	None posted
Sep 30, 1986	Supplement 27Manufacturing · Standard review	Approved	None posted
May 20, 1986	Supplement 26Manufacturing · Standard review	Approved	None posted
Aug 10, 1983	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 2, 1983	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 15, 1981	Supplement 19Labeling	Approved	None posted
Jun 3, 1981	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 8, 1979	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 30, 1978	Supplement 15Labeling	Approved	None posted
Jan 9, 1978	Supplement 11Labeling	Approved	None posted
Jan 28, 1977	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 5, 1975	Supplement 10Labeling	Approved	None posted
Mar 1, 1956	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 10151
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