Mesantoin

NDA 6008, held by Novartis. Mephenytoin.

As of Nov 13, 2026, NDA 6008 (Mesantoin), held by Novartis, was first approved by FDA on Oct 23, 1946, with 31 approved supplements and 0 published complete response letters.

First approved: Oct 23, 1946
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Oct 23, 1946	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Mesantoin100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Mephenytoin	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements


Apr 2, 2001	Supplement 49Manufacturing	Approved	None posted
Apr 23, 1999	Supplement 48Manufacturing	Approved	None posted
Jul 15, 1997	Supplement 46Manufacturing	Approved	None posted
Jul 23, 1996	Supplement 39Manufacturing	Approved	None posted
Feb 21, 1996	Supplement 45Manufacturing	Approved	None posted
Aug 14, 1995	Supplement 43Manufacturing	Approved	None posted
Feb 15, 1995	Supplement 44Manufacturing	Approved	None posted
Dec 14, 1994	Supplement 42Labeling	Approved	None posted
Dec 14, 1994	Supplement 41Labeling	Approved	None posted
Nov 23, 1994	Supplement 40Manufacturing	Approved	None posted
Jul 1, 1994	Supplement 38Manufacturing	Approved	None posted
Nov 10, 1987	Supplement 35Labeling	Approved	None posted
Aug 27, 1986	Supplement 34Manufacturing	Approved	None posted
Aug 27, 1986	Supplement 32Manufacturing	Approved	None posted
Dec 5, 1984	Supplement 33Manufacturing	Approved	None posted
Aug 8, 1983	Supplement 31Manufacturing	Approved	None posted
Jul 20, 1981	Supplement 30Manufacturing	Approved	None posted
Mar 6, 1981	Supplement 27Manufacturing	Approved	None posted
Jul 24, 1980	Supplement 26Labeling	Approved	None posted
Jun 14, 1979	Supplement 25Manufacturing	Approved	None posted
Sep 28, 1978	Supplement 24Manufacturing	Approved	None posted
Feb 13, 1978	Supplement 23Manufacturing	Approved	None posted
Feb 18, 1977	Supplement 22Manufacturing	Approved	None posted
Jul 23, 1976	Supplement 20Manufacturing	Approved	None posted
Jul 20, 1976	Supplement 21Manufacturing	Approved	None posted
May 4, 1976	Supplement 19Manufacturing	Approved	None posted
May 4, 1976	Supplement 18Manufacturing	Approved	None posted
Nov 10, 1975	Supplement 15Labeling	Approved	None posted
Jul 1, 1975	Supplement 17Manufacturing	Approved	None posted
Sep 20, 1974	Supplement 14Manufacturing	Approved	None posted
Aug 29, 1974	Supplement 11Manufacturing	Approved	None posted
Oct 23, 1946	Original application	Approved	None posted

Identifiers

Application: NDA 6008
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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