Details for New Drug Application (NDA): 020397

NDA 020397 describes ZANAFLEX, which is a drug marketed by Legacy Pharma Usa and is included in two NDAs. It is available from four suppliers. Additional details are available on the ZANAFLEX profile page.

The generic ingredient in ZANAFLEX is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for 020397

Tradename:	ZANAFLEX
Applicant:	Legacy Pharma Usa
Ingredient:	tizanidine hydrochloride
Patents:	0

Pharmacology for NDA: 020397

Mechanism of Action

Adrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 020397

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZANAFLEX	tizanidine hydrochloride	TABLET;ORAL	020397	NDA	Covis Pharma US, Inc	70515-594	70515-594-15	150 TABLET in 1 BOTTLE (70515-594-15)
ZANAFLEX	tizanidine hydrochloride	TABLET;ORAL	020397	NDA	Legacy Pharma USA, Inc.	83107-004	83107-004-15	150 TABLET in 1 BOTTLE (83107-004-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4MG BASE
Approval Date:	Nov 27, 1996	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 4, 2000	TE:		RLD:	Yes

Complete Access Available with Subscription