Last Updated: September 25, 2026

Details for New Drug Application (NDA): 212253

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NDA 212253 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Ajenat Pharms, Anda Repository, 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, Somerset Theraps Llc, Sun Pharm Industries, Teva Pharms Usa Inc, and Watson Labs, and is included in thirty-five NDAs. It is available from eighteen suppliers. Additional details are available on the CHLORZOXAZONE profile page.

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

Summary for 212253

Tradename:	CHLORZOXAZONE
Applicant:	Novitium Pharma
Ingredient:	chlorzoxazone
Patents:	0

Medical Subject Heading (MeSH) Categories for 212253

Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	375MG
Approval Date:	Nov 27, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Nov 27, 2019	TE:	AB	RLD:	No

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