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Serving 500+ biopharmaceutical companies globally:

Generated: September 20, 2017

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Details for New Drug Application (NDA): 021447

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NDA 021447 describes ZANAFLEX, which is a drug marketed by Acorda and is included in two NDAs. It is available from seven 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 suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for NDA: 021447

Tradename:	1
Applicant:	1
Ingredient:	1
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	0591-2788-86	150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2788-86)
ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447	NDA	Actavis Pharma, Inc.	0591-2789	0591-2789-86	150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2789-86)

Summary 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

Summary 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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.