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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077691

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NDA 077691 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 077691

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077691

Suppliers and Packaging for NDA: 077691

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 077691 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7704 0615-7704-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7704-39)
SIMVASTATIN simvastatin TABLET;ORAL 077691 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7705 0615-7705-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7705-39)

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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