Flexeril

NDA 17821, held by Janssen Res And Dev. Cyclobenzaprine Hydrochloride.

As of Nov 14, 2026, NDA 17821 (Flexeril), held by Janssen Res And Dev, was first approved by FDA on Aug 26, 1977, with 31 approved supplements and 0 published complete response letters.

First approved: Aug 26, 1977
Review: Priority
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

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


Feb 3, 2003	Supplement 45Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 26, 1977	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Flexeril5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cyclobenzaprine Hydrochloride	DiscontinuedReference drug
Flexeril10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Cyclobenzaprine Hydrochloride	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements


Apr 11, 2013	Supplement 51Labeling	Approved	Letter Label
Feb 3, 2003	Supplement 45Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Nov 5, 2002	Supplement 47Manufacturing · Priority review	Approved	None posted
Oct 3, 2002	Supplement 46Manufacturing · Priority review	Approved	None posted
Sep 15, 1998	Supplement 41Manufacturing · Priority review	Approved	None posted
Jun 21, 1997	Supplement 24Labeling · Priority review	Approved	None posted
Nov 29, 1996	Supplement 40Manufacturing · Priority review	Approved	None posted
Mar 1, 1996	Supplement 39Manufacturing · Priority review	Approved	None posted
Aug 18, 1994	Supplement 37Manufacturing · Priority review	Approved	None posted
Jun 9, 1994	Supplement 32Manufacturing · Priority review	Approved	None posted
Jan 10, 1990	Supplement 33Manufacturing · Priority review	Approved	None posted
Apr 8, 1988	Supplement 31Manufacturing · Priority review	Approved	None posted
May 30, 1986	Supplement 29Labeling · Priority review	Approved	None posted
Jan 16, 1986	Supplement 26Labeling · Priority review	Approved	None posted
Feb 24, 1984	Supplement 25Manufacturing · Priority review	Approved	None posted
Jun 21, 1983	Supplement 19Manufacturing · Priority review	Approved	None posted
Jan 4, 1983	Supplement 23Manufacturing · Priority review	Approved	None posted
Jun 3, 1982	Supplement 16Labeling · Priority review	Approved	None posted
May 13, 1982	Supplement 21Manufacturing · Priority review	Approved	None posted
Apr 1, 1982	Supplement 20Manufacturing · Priority review	Approved	None posted
May 26, 1981	Supplement 18Manufacturing · Priority review	Approved	None posted
May 26, 1981	Supplement 17Manufacturing · Priority review	Approved	None posted
Dec 2, 1980	Supplement 15Manufacturing · Priority review	Approved	None posted
Oct 10, 1980	Supplement 14Manufacturing · Priority review	Approved	None posted
Oct 10, 1980	Supplement 13Manufacturing · Priority review	Approved	None posted
Oct 10, 1980	Supplement 12Labeling · Priority review	Approved	None posted
Aug 21, 1980	Supplement 11Manufacturing · Priority review	Approved	None posted
May 31, 1979	Supplement 8Labeling · Priority review	Approved	None posted
May 3, 1979	Supplement 7Manufacturing · Priority review	Approved	None posted
Mar 14, 1978	Supplement 2Labeling · Priority review	Approved	None posted
Mar 2, 1978	Supplement 4Labeling · Priority review	Approved	None posted
Aug 26, 1977	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 17821
Drugs@FDA: Overview at FDA
Company: Janssen Research & Development

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