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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Argus Health
Boehringer Ingelheim

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076281

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NDA 076281 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 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 076281
Applicant:Oxford Pharms
Ingredient:tizanidine hydrochloride
Therapeutic Class:Antispasticity Agents
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Oct 20, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Oct 20, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Johnson and Johnson
Harvard Business School

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