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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Cipla
Teva
Federal Trade Commission
UBS
US Department of Justice
Deloitte
Johnson and Johnson
US Army

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076052

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NDA 076052 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 076052
Tradename:SIMVASTATIN
Applicant:Ivax Sub Teva Pharms
Ingredient:simvastatin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076052
Suppliers and Packaging for NDA: 076052
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 076052 ANDA Teva Pharmaceuticals USA Inc 0093-7152 N 0093-7152-98
SIMVASTATIN simvastatin TABLET;ORAL 076052 ANDA Teva Pharmaceuticals USA, Inc. 0093-7153 N 0093-7153-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 23, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 23, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 23, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Fish and Richardson
US Department of Justice
Mallinckrodt
Medtronic
Moodys
Cerilliant
Cantor Fitzgerald
Chinese Patent Office

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