Chlorzoxazone

ANDA 89895, held by Barr. Chlorzoxazone.

As of Nov 15, 2026, ANDA 89895 (Chlorzoxazone), held by Barr, was first approved by FDA on May 4, 1988, with 15 approved supplements and 0 published complete response letters.

First approved: May 4, 1988
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 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	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Dec 21, 1999	Supplement 16Manufacturing	Approved	None posted
Sep 7, 1999	Supplement 15Manufacturing	Approved	None posted
Sep 7, 1999	Supplement 14Manufacturing	Approved	None posted
May 20, 1999	Supplement 13Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 12Manufacturing	Approved	None posted
Jul 6, 1998	Supplement 11Manufacturing	Approved	None posted
Jun 20, 1997	Supplement 10Manufacturing	Approved	None posted
Feb 5, 1996	Supplement 9Labeling	Approved	None posted
Dec 23, 1994	Supplement 8Manufacturing	Approved	None posted
Oct 17, 1994	Supplement 7Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 6Manufacturing	Approved	None posted
Oct 5, 1993	Supplement 5Labeling	Approved	None posted
Apr 3, 1992	Supplement 4Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 2Manufacturing	Approved	None posted
Feb 6, 1991	Supplement 1Labeling	Approved	None posted
May 4, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89895
Drugs@FDA: Overview at FDA
Company: Barr 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