Chlorzoxazone

ANDA 81040, held by Watson Labs. Chlorzoxazone.

As of Nov 15, 2026, ANDA 81040 (Chlorzoxazone), held by Watson Labs, was first approved by FDA on Aug 22, 1989, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 22, 1989
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 22, 1989	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorzoxazone500MG · tablet;oral	Chlorzoxazone	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Apr 12, 2001	Supplement 12Manufacturing	Approved	None posted
Mar 21, 2000	Supplement 10Manufacturing	Approved	None posted
Jul 8, 1997	Supplement 8Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 5Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 6Manufacturing	Approved	None posted
Mar 4, 1996	Supplement 4Labeling	Approved	None posted
May 15, 1995	Supplement 2Manufacturing	Approved	None posted
May 15, 1995	Supplement 3Manufacturing	Approved	None posted
Apr 25, 1994	Supplement 1Manufacturing	Approved	None posted
Aug 22, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 81040
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