Chlorzoxazone

ANDA 86901, held by Watson Labs. Chlorzoxazone.

As of Nov 15, 2026, ANDA 86901 (Chlorzoxazone), held by Watson Labs, was first approved by FDA on Oct 6, 1981, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 6, 1981
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
Oct 6, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorzoxazone250MG · tablet;oral	Chlorzoxazone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Mar 21, 1996	Supplement 13Labeling	Approved	None posted
Dec 26, 1991	Supplement 6Labeling	Approved	None posted
Oct 6, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86901
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