Chlorzoxazone

ANDA 88928, held by Actavis Elizabeth. Chlorzoxazone.

As of Nov 15, 2026, ANDA 88928 (Chlorzoxazone), held by Actavis Elizabeth, was first approved by FDA on May 8, 1987, with 7 approved supplements and 0 published complete response letters.

First approved: May 8, 1987
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 8, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorzoxazone250MG · tablet;oral	Chlorzoxazone	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Apr 19, 1999	Supplement 7Manufacturing	Approved	None posted
Dec 11, 1995	Supplement 4Manufacturing	Approved	None posted
Dec 11, 1995	Supplement 5Labeling	Approved	None posted
Dec 11, 1995	Supplement 6Manufacturing	Approved	None posted
Oct 18, 1993	Supplement 3Labeling	Approved	None posted
Sep 16, 1991	Supplement 1Manufacturing	Approved	None posted
Sep 16, 1991	Supplement 2Labeling	Approved	None posted
May 8, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 88928
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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