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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078868

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NDA 078868 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Zydus Pharms Usa Inc, Actavis Elizabeth, Apotex, Barr, Casi Pharms Inc, Dr Reddys Labs Inc, Epic Pharma Llc, Ivax Sub Teva Pharms, Mylan, Oxford Pharms, Sun Pharm Inds Inc, Teva, and Unichem Labs Ltd, and is included in twenty NDAs. It is available from forty-six suppliers. Additional details are available on the TIZANIDINE HYDROCHLORIDE profile page.

The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 078868
Tradename:TIZANIDINE HYDROCHLORIDE
Applicant:Apotex Inc
Ingredient:tizanidine hydrochloride
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078868
Mechanism of ActionAdrenergic alpha2-Agonists
Suppliers and Packaging for NDA: 078868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 078868 ANDA AvKARE, Inc. 42291-810 N 42291-810-15
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride CAPSULE;ORAL 078868 ANDA AvKARE, Inc. 42291-811 N 42291-811-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 2MG BASE
Approval Date:Feb 3, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4MG BASE
Approval Date:Feb 3, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 6MG BASE
Approval Date:Feb 3, 2012TE:ABRLD:No

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Argus Health
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QuintilesIMS
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