Skelaxin

NDA 13217, held by King Pharms. Metaxalone.

As of Nov 13, 2026, NDA 13217 (Skelaxin), held by King Pharms, was first approved by FDA on Aug 13, 1962, with 37 approved supplements and 0 published complete response letters.

First approved: Aug 13, 1962
Review: Standard
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below

Date	Submission	Status	Documents
Aug 13, 1962	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Skelaxin400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metaxalone	DiscontinuedReference drug
Skelaxin800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metaxalone	DiscontinuedReference drug

All 38 submissions, including labeling and manufacturing supplements


Jun 21, 2024	Supplement 62Labeling · Standard review	Approved	Label Letter
Mar 6, 2018	Supplement 57Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 58Manufacturing · Standard review	Approved	None posted
Sep 29, 2014	Supplement 56Manufacturing · Standard review	Approved	None posted
Jan 27, 2014	Supplement 55Manufacturing · Standard review	Approved	None posted
Oct 31, 2008	Supplement 53Labeling · Standard review	Approved	Label Letter
Nov 24, 2006	Supplement 46Labeling · Standard review	Approved	Letter Label
Aug 30, 2002	Supplement 36Manufacturing · Standard review	Approved	Letter Label
Jun 20, 2002	Supplement 44Labeling · Standard review	Approved	Review Letter
Jun 3, 2002	Supplement 45Manufacturing · Standard review	Approved	Review
Apr 16, 2002	Supplement 43Manufacturing · Standard review	Approved	Review
Sep 26, 2001	Supplement 41Manufacturing · Standard review	Approved	Review
Jan 31, 2001	Supplement 40Manufacturing · Standard review	Approved	Review
May 4, 2000	Supplement 37Manufacturing · Standard review	Approved	Review
Apr 13, 1999	Supplement 34Manufacturing · Standard review	Approved	None posted
Apr 13, 1999	Supplement 32Manufacturing · Standard review	Approved	None posted
Sep 18, 1998	Supplement 35Manufacturing · Standard review	Approved	None posted
Mar 26, 1998	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 7, 1997	Supplement 30Manufacturing · Standard review	Approved	None posted
Mar 20, 1997	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 28, 1995	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 27, 1995	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 5, 1995	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 27, 1992	Supplement 25Manufacturing · Standard review	Approved	None posted
Feb 28, 1989	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 26, 1987	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 31, 1985	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 4, 1985	Supplement 17Labeling	Approved	None posted
May 31, 1985	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 27, 1984	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 27, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
Jan 16, 1981	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 16, 1981	Supplement 11Labeling	Approved	None posted
Apr 15, 1980	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 13, 1980	Supplement 9Labeling	Approved	None posted
Feb 26, 1979	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 4, 1977	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 13, 1962	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 13217
Drugs@FDA: Overview at FDA
Company: King 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