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Generated: November 19, 2018

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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 Covis Pharma Bv 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-one 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021447
Mechanism of ActionAdrenergic 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Aug 29, 2002TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4MG BASE
Approval Date:Aug 29, 2002TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 6MG BASE
Approval Date:Aug 29, 2002TE:ABRLD:Yes

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