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Last Updated: March 21, 2023

Details for New Drug Application (NDA): 020397

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NDA 020397 describes ZANAFLEX, which is a drug marketed by Legacy Pharma and is included in two NDAs. It is available from three 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 020397
Applicant:Legacy Pharma
Ingredient:tizanidine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 020397
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 020397
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZANAFLEX tizanidine hydrochloride TABLET;ORAL 020397 NDA Covis Pharma US, Inc 70515-594 70515-594-15 150 TABLET in 1 BOTTLE (70515-594-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Nov 27, 1996TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 4, 2000TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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