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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 089859

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NDA 089859 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Ajenat Pharms, Anda Repository, Appco, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Corepharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Novitium Pharma, Ohm Labs, Ph Health, Pioneer Pharms, Rising, Senores Pharms, Sun Pharm Industries, Teva Pharms Usa Inc, and Watson Labs, and is included in thirty-five NDAs. It is available from twenty suppliers. Additional details are available on the CHLORZOXAZONE profile page.

The generic ingredient in CHLORZOXAZONE is chlorzoxazone. There are sixteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.

Summary for 089859

Tradename:	CHLORZOXAZONE
Applicant:	Watson Labs
Ingredient:	chlorzoxazone
Patents:	0

Pharmacology for NDA: 089859

Physiological Effect	Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 089859

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 089859

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	089859	ANDA	Actavis Pharma, Inc.	0591-2520	0591-2520-01	100 TABLET in 1 BOTTLE, PLASTIC (0591-2520-01)
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	089859	ANDA	Actavis Pharma, Inc.	0591-2520	0591-2520-05	500 TABLET in 1 BOTTLE, PLASTIC (0591-2520-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 4, 1988	TE:	AA	RLD:	No

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