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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Chinese Patent Office
Queensland Health

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076280

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NDA 076280 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 076280

Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076280

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 076280

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076280 ANDA Eon Labs, Inc. 0185-0034 0185-0034-10 1000 TABLET in 1 BOTTLE (0185-0034-10)
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076280 ANDA Eon Labs, Inc. 0185-0034 0185-0034-51 150 TABLET in 1 BOTTLE (0185-0034-51)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Nov 26, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jun 27, 2002TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Cantor Fitzgerald

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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