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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210961

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NDA 210961 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 210961

Tradename:	CHLORZOXAZONE
Applicant:	Anda Repository
Ingredient:	chlorzoxazone
Patents:	0

Pharmacology for NDA: 210961

Physiological Effect	Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 210961

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 210961

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	210961	ANDA	Cintex Services, LLC	24470-940	24470-940-10	100 TABLET in 1 BOTTLE (24470-940-10)
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	210961	ANDA	Cintex Services, LLC	24470-940	24470-940-50	500 TABLET in 1 BOTTLE (24470-940-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jan 22, 2024	TE:	AA	RLD:	No

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