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Last Updated: November 24, 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 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-three 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
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: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

Expired US Patents for NDA 021447

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

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