Details for New Drug Application (NDA): 215158

NDA 215158 describes CHLORZOXAZONE, which is a drug marketed by Acme Labs, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Belcher, Corepharma, Dr Reddys Labs Sa, Endo Operations, Glenmark Pharms Ltd, I3 Pharms, 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 215158

Tradename:	CHLORZOXAZONE
Applicant:	Senores Pharms
Ingredient:	chlorzoxazone
Patents:	0

Pharmacology for NDA: 215158

Physiological Effect

Centrally-mediated Muscle Relaxation

Medical Subject Heading (MeSH) Categories for 215158

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 215158

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	215158	ANDA	Cintex Services, LLC	24470-923	24470-923-10	100 TABLET in 1 BOTTLE (24470-923-10)
CHLORZOXAZONE	chlorzoxazone	TABLET;ORAL	215158	ANDA	Cintex Services, LLC	24470-923	24470-923-60	60 TABLET in 1 BOTTLE (24470-923-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jul 29, 2021	TE:	AA	RLD:	No

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