Chlorzoxazone

ANDA 89852, held by Rising. Chlorzoxazone.

As of Nov 15, 2026, ANDA 89852 (Chlorzoxazone), held by Rising, was first approved by FDA on May 4, 1988, with 5 approved supplements and 0 published complete response letters.

First approved: May 4, 1988
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
May 4, 1988	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 5Labeling	Approved	None posted
Dec 30, 1994	Supplement 4Manufacturing	Approved	None posted
Mar 5, 1991	Supplement 3Manufacturing	Approved	None posted
Aug 1, 1989	Supplement 2Labeling	Approved	None posted
Nov 4, 1988	Supplement 1Manufacturing	Approved	None posted
May 4, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 89852
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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