Chlorzoxazone

ANDA 40137, held by Watson Labs. Chlorzoxazone.

As of Nov 15, 2026, ANDA 40137 (Chlorzoxazone), held by Watson Labs, was first approved by FDA on Aug 9, 1996, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 9, 1996
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 9, 1996	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorzoxazone500MG · tablet;oral	Chlorzoxazone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 16, 1997	Supplement 2Manufacturing	Approved	None posted
Jan 31, 1997	Supplement 1Manufacturing	Approved	None posted
Aug 9, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 40137
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