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Serving 500+ biopharmaceutical companies globally:

Citi
AstraZeneca
Farmers Insurance
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McKinsey
Teva
Chinese Patent Office
Baxter
Cipla

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076685

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NDA 076685 describes SIMVASTATIN, which is a drug marketed by Lupin, Biocon Limited, Oxford Pharms, Zydus Pharms Usa, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Accord Hlthcare, Synthon Pharms, Sandoz Inc, Mylan Pharms Inc, Tcg Fluent Pharma, Micro Labs Ltd, Sun Pharm Inds Ltd, Watson Labs Teva, Aurobindo Pharma, and Hetero Labs Ltd Iii, and is included in sixteen NDAs. It is available from sixty-one suppliers. There is one patent protecting this drug. 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-two suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

Summary for NDA: 076685

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076685

Suppliers and Packaging for NDA: 076685

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN
simvastatin
TABLET;ORAL 076685 ANDA Cobalt Laboratories Inc. 16252-506 16252-506-00 91575 TABLET in 1 PAIL (16252-506-00)
SIMVASTATIN
simvastatin
TABLET;ORAL 076685 ANDA Cobalt Laboratories Inc. 16252-507 16252-507-00 45787 TABLET in 1 PAIL (16252-507-00)

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


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
Cerilliant
Johnson and Johnson
Citi
Covington
Baxter
Federal Trade Commission
Julphar
McKinsey

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.

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