Chlorzoxazone

ANDA 40113, held by Actavis Elizabeth. Chlorzoxazone.

As of Nov 15, 2026, ANDA 40113 (Chlorzoxazone), held by Actavis Elizabeth, was first approved by FDA on Sep 29, 1995, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 29, 1995
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 29, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorzoxazone500MG · tablet;oral	Chlorzoxazone	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Mar 25, 1996	Supplement 1Manufacturing	Approved	None posted
Sep 29, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 40113
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