Details for New Drug Application (NDA): 212743

NDA 212743 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Ajenat Pharms, Aurobindo Pharma Ltd, Barr, 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 eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the chlorzoxazone profile page.

Summary for 212743

Tradename:	CHLORZOXAZONE
Applicant:	Endo Operations
Ingredient:	chlorzoxazone
Patents:	0

Pharmacology for NDA: 212743

Physiological Effect

Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 212743

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 212743

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	212743	ANDA	Endo USA, Inc.	0254-2005	0254-2005-01	100 TABLET in 1 BOTTLE (0254-2005-01)
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	212743	ANDA	Endo USA, Inc.	0254-2053	0254-2053-01	100 TABLET in 1 BOTTLE (0254-2053-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	750MG
Approval Date:	Nov 2, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	375MG
Approval Date:	Apr 29, 2021	TE:	AB	RLD:	No

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