.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries

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

Serving leading biopharmaceutical companies globally:

Merck
Fuji
Dow
US Army
Chinese Patent Office
QuintilesIMS
UBS
Baxter
McKesson
Harvard Business School

Generated: December 17, 2017

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, Sandoz Inc, Sun Pharm Inds Ltd, Viva Hlthcare, Watson Labs Teva, and Zydus Pharms Usa, and is included in sixteen NDAs. It is available from sixty-four 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-six suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

Summary for 077837

Tradename:1
Applicant:1
Ingredient:1
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 10544-486-30 30 TABLET, FILM COATED in 1 BOTTLE (10544-486-30)
SIMVASTATIN simvastatin TABLET;ORAL 077837 ANDA Blenheim Pharmacal, Inc. 10544-487 10544-487-30 30 TABLET, FILM COATED in 1 BOTTLE (10544-487-30)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 20, 2006TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

US Department of Justice
Moodys
AstraZeneca
Harvard Business School
Mallinckrodt
Citi
Cantor Fitzgerald
McKesson
Federal Trade Commission
Novartis

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot