Chlorzoxazone

ANDA 87981, held by Chartwell Rx. Chlorzoxazone.

As of Nov 15, 2026, ANDA 87981 (Chlorzoxazone), held by Chartwell Rx, was first approved by FDA on Sep 20, 1983, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 20, 1983
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 20, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorzoxazone250MG · tablet;oral	Chlorzoxazone	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 5, 1996	Supplement 7Labeling	Approved	None posted
Oct 26, 1993	Supplement 6Labeling	Approved	None posted
Mar 15, 1991	Supplement 5Labeling	Approved	None posted
Oct 27, 1988	Supplement 4Manufacturing	Approved	None posted
Jul 5, 1985	Supplement 1Manufacturing	Approved	None posted
Sep 20, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87981
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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