Details for New Drug Application (NDA): 212053

NDA 212053 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Belcher, Chartwell Rx, Corepharma, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, Mikart, Novitium Pharma, Ohm Labs, Pioneer Pharms, Rising, Senores Pharms, Strides Pharma, Sun Pharm Industries, Teva Pharms Usa Inc, Upsher Smith Labs, and Watson Labs, and is included in thirty-five NDAs. It is available from twenty-five 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-five suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.

Summary for 212053

Tradename:	CHLORZOXAZONE
Applicant:	Chartwell Rx
Ingredient:	chlorzoxazone
Patents:	0

Pharmacology for NDA: 212053

Physiological Effect

Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 212053

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 212053

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	212053	ANDA	TruPharma, LLC	52817-230	52817-230-10	100 TABLET in 1 BOTTLE, PLASTIC (52817-230-10)
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	212053	ANDA	TruPharma, LLC	52817-231	52817-231-10	100 TABLET in 1 BOTTLE, PLASTIC (52817-231-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	375MG
Approval Date:	Sep 14, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Sep 14, 2020	TE:		RLD:	No

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