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

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Cantor Fitzgerald
Farmers Insurance
US Army
Julphar
Fuji
AstraZeneca
US Department of Justice
Healthtrust

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077837

« Back to Dashboard

NDA 077837 describes SIMVASTATIN, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Limited, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Hisun Pharm Hangzhou, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Oxford Pharms, Sun Pharm Inds Ltd, Viva Hlthcare, Watson Labs Teva, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in sixteen NDAs. It is available from sixty-three suppliers. Additional details are available on the SIMVASTATIN profile page.

The generic ingredient in SIMVASTATIN is simvastatin. There are thirty-nine drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 077837
Tradename:SIMVASTATIN
Applicant:Zydus Pharms Usa
Ingredient:simvastatin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077837
Suppliers and Packaging for NDA: 077837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 077837 ANDA Blenheim Pharmacal, Inc. 10544-486 E 10544-486-30
SIMVASTATIN simvastatin TABLET;ORAL 077837 ANDA Blenheim Pharmacal, Inc. 10544-487 E 10544-487-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 20, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 20, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 20, 2006TE: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:

US Army
Mallinckrodt
Teva
UBS
Deloitte
Harvard Business School
McKinsey
US Department of Justice
Boehringer Ingelheim

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.