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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Julphar
Colorcon
Harvard Business School
Cipla
Johnson and Johnson
Deloitte
Federal Trade Commission
Dow
McKesson

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078103

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NDA 078103 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 078103
Tradename:SIMVASTATIN
Applicant:Lupin
Ingredient:simvastatin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078103
Suppliers and Packaging for NDA: 078103
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 078103 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7992 N 0615-7992-39
SIMVASTATIN simvastatin TABLET;ORAL 078103 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7992 N 0615-7992-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 11, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 11, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:May 11, 2007TE:ABRLD:No

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