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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 eight 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-four suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for NDA: 021447

Tradename:
ZANAFLEX
Applicant:
Acorda
Ingredient:
tizanidine hydrochloride
Patents:0
Therapeutic Class:Antispasticity Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Aug 29, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4MG BASE
Approval Date:Aug 29, 2002TE:ABRLD:No

Summary for product number 003

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


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