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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 214365

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NDA 214365 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 214365

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

Medical Subject Heading (MeSH) Categories for 214365

Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 27, 2023	TE:		RLD:	No

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