Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Harvard Business School
Queensland Health
US Army
Argus Health

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076416

« Back to Dashboard

NDA 076416 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-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 suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 076416
Applicant:Sun Pharm Inds Inc
Ingredient:tizanidine hydrochloride
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 tizanidine hydrochloride TABLET;ORAL 076416 ANDA AvKARE, Inc. 42291-808 N 42291-808-15
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride TABLET;ORAL 076416 ANDA AvKARE, Inc. 42291-809 N 42291-809-15

Profile for product number 001

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

Profile for product number 002

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
US Army

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.