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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Argus Health
Johnson and Johnson
Daiichi Sankyo
Cantor Fitzgerald

Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076416

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NDA 076416 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Mylan Pharms Inc, Sun Pharm Inds Inc, Ivax Sub Teva Pharms, Zydus Pharms Usa Inc, Apotex, Epic Pharma Llc, Mylan, Apotex Inc, Par Pharm Inc, Barr, Sandoz Inc, Oxford Pharms, Actavis Elizabeth, Unichem Labs Ltd, Teva, and Dr Reddys Labs Inc, and is included in eighteen NDAs. It is available from forty-four 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-eight suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.

Summary for NDA: 076416

Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076416

Mechanism of ActionAdrenergic alpha2-Agonists

Suppliers and Packaging for NDA: 076416

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
tizanidine hydrochloride
TABLET;ORAL 076416 ANDA AvKARE, Inc. 42291-808 42291-808-15 150 TABLET in 1 BOTTLE (42291-808-15)
tizanidine hydrochloride
TABLET;ORAL 076416 ANDA AvKARE, Inc. 42291-809 42291-809-15 150 TABLET in 1 BOTTLE (42291-809-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Sep 29, 2003TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Sep 29, 2003TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Cantor Fitzgerald
Argus Health

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