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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 021447

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

Summary for 021447

Tradename:	ZANAFLEX
Applicant:	Legacy Pharma Usa
Ingredient:	tizanidine hydrochloride
Patents:	0
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 AUTHORIZED GENERIC	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 AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-2789	0591-2789-86	150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (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

Expired US Patents for NDA 021447

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-003	Aug 29, 2002	⤷ Try a Trial	⤷ Try a Trial
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-001	Aug 29, 2002	⤷ Try a Trial	⤷ Try a Trial
Legacy Pharma Usa	ZANAFLEX	tizanidine hydrochloride	CAPSULE;ORAL	021447-002	Aug 29, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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