Chlorzoxazone

ANDA 89970, held by Sun Pharm Industries. Chlorzoxazone.

As of Nov 15, 2026, ANDA 89970 (Chlorzoxazone), held by Sun Pharm Industries, was first approved by FDA on Sep 27, 1990, with 9 approved supplements and 0 published complete response letters.

First approved: Sep 27, 1990
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Sep 27, 1990	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorzoxazone500MG · tablet;oral	Chlorzoxazone	Discontinued

All 10 submissions, including labeling and manufacturing supplements


May 16, 2000	Supplement 8Manufacturing	Approved	None posted
May 16, 2000	Supplement 9Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 7Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 6Manufacturing	Approved	None posted
Jun 22, 1995	Supplement 5Manufacturing	Approved	None posted
Aug 11, 1994	Supplement 4Manufacturing	Approved	None posted
Jan 12, 1994	Supplement 3Manufacturing	Approved	None posted
Jun 30, 1993	Supplement 2Labeling	Approved	None posted
Nov 16, 1990	Supplement 1Labeling	Approved	None posted
Sep 27, 1990	Original application	Approved	None posted

Identifiers

Application: ANDA 89970
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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