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Generated: June 26, 2019

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Details for New Drug Application (NDA): 078034

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NDA 078034 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, Micro Labs, Mylan Pharms Inc, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in sixteen NDAs. It is available from fifty-nine suppliers. Additional details are available on the SIMVASTATIN profile page.

The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 078034
Tradename:SIMVASTATIN
Applicant:Biocon Limited
Ingredient:simvastatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078034
Suppliers and Packaging for NDA: 078034
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 078034 ANDA Aphena Pharma Solutions - Tennessee, Inc. 43353-768 43353-768-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-768-15)
SIMVASTATIN simvastatin TABLET;ORAL 078034 ANDA Aphena Pharma Solutions - Tennessee, Inc. 43353-773 43353-773-15 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-773-15)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Covington
US Department of Justice
Daiichi Sankyo
Express Scripts
AstraZeneca

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