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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076533

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NDA 076533 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, Dr Reddys Labs Inc, Epic Pharma Llc, Ivax Sub Teva Pharms, Mylan, Oxford Pharms, Sandoz Inc, Sun Pharm Inds Inc, Teva, and Unichem Labs Ltd, and is included in nineteen NDAs. It is available from forty-seven 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. Fifty-one suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for 076533

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076533

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 076533

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076533 ANDA Major Pharmaceuticals 0904-6418 0904-6418-61 100 BLISTER PACK in 1 CARTON (0904-6418-61) > 1 TABLET in 1 BLISTER PACK
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076533 ANDA Blenheim Pharmacal, Inc. 10544-576 10544-576-02 120 TABLET in 1 BOTTLE (10544-576-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Jan 16, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jan 16, 2004TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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