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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021447

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NDA 021447 describes ZANAFLEX, which is a drug marketed by Covis Pharma Bv and is included in two NDAs. It is available from six 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. Forty-nine suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for 021447

Tradename:	ZANAFLEX
Applicant:	Covis Pharma Bv
Ingredient:	tizanidine hydrochloride
Patents:	0
Therapeutic Class:	Antispasticity Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021447

Mechanism of Action	Adrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 021447

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447	NDA	Actavis Pharma, Inc.	0591-2788	N	0591-2788-86
ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447	NDA	Actavis Pharma, Inc.	0591-2789	N	0591-2789-86

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 2MG BASE
Approval Date:	Aug 29, 2002	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 4MG BASE
Approval Date:	Aug 29, 2002	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 6MG BASE
Approval Date:	Aug 29, 2002	TE:	AB	RLD:	Yes

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