Details for New Drug Application (NDA): 040861

NDA 040861 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 040861

Tradename:	CHLORZOXAZONE
Applicant:	Mikart
Ingredient:	chlorzoxazone
Patents:	0

Pharmacology for NDA: 040861

Physiological Effect

Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 040861

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 040861

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	040861	ANDA	Trigen Laboratories, LLC	13811-717	13811-717-10	100 TABLET in 1 BOTTLE, PLASTIC (13811-717-10)
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	040861	ANDA	Trigen Laboratories, LLC	13811-718	13811-718-10	100 TABLET in 1 BOTTLE, PLASTIC (13811-718-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	375MG
Approval Date:	Jun 1, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Jun 1, 2010	TE:	AB	RLD:	No

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