Chlorzoxazone

Relieves discomfort associated with acute, painful musculoskeletal conditions. ANDA 89859, held by Watson Labs. Chlorzoxazone.

As of Nov 15, 2026, ANDA 89859 (Chlorzoxazone), held by Watson Labs, was first approved by FDA on May 4, 1988, with 31 approved supplements and 0 published complete response letters.

First approved: May 4, 1988
Supplements approved: 31
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
May 4, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorzoxazone500MG · tablet;oral	Chlorzoxazone	Rx

All 32 submissions, including labeling and manufacturing supplements


Aug 30, 2001	Supplement 31Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 30Manufacturing	Approved	None posted
Nov 19, 1999	Supplement 29Manufacturing	Approved	None posted
Mar 9, 1998	Supplement 28Manufacturing	Approved	None posted
Oct 17, 1997	Supplement 27Manufacturing	Approved	None posted
Jan 7, 1997	Supplement 25Manufacturing	Approved	None posted
Dec 13, 1996	Supplement 26Manufacturing	Approved	None posted
Aug 8, 1996	Supplement 3Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 23Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 22Manufacturing	Approved	None posted
Oct 3, 1995	Supplement 21Manufacturing	Approved	None posted
Sep 20, 1995	Supplement 24Labeling	Approved	None posted
Mar 2, 1995	Supplement 20Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 19Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 18Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 17Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 16Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 15Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 14Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 13Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 12Manufacturing	Approved	None posted
Jan 26, 1994	Supplement 11Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 10Manufacturing	Approved	None posted
May 25, 1993	Supplement 8Manufacturing	Approved	None posted
May 25, 1993	Supplement 7Manufacturing	Approved	None posted
Apr 1, 1993	Supplement 9Manufacturing	Approved	None posted
Apr 1, 1993	Supplement 6Manufacturing	Approved	None posted
Dec 30, 1992	Supplement 4Manufacturing	Approved	None posted
Sep 25, 1992	Supplement 5Labeling	Approved	None posted
Dec 9, 1991	Supplement 2Manufacturing	Approved	None posted
Dec 9, 1991	Supplement 1Manufacturing	Approved	None posted
May 4, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89859
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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