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Serving leading biopharmaceutical companies globally:

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Cerilliant

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090868

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NDA 090868 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, Viva Hlthcare, 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-two 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-three suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

Summary for NDA: 090868

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

Pharmacology for NDA: 090868

Suppliers and Packaging for NDA: 090868

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN
simvastatin
TABLET;ORAL 090868 ANDA Cardinal Health 55154-5373 55154-5373-0 10 BLISTER PACK in 1 BAG (55154-5373-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK
SIMVASTATIN
simvastatin
TABLET;ORAL 090868 ANDA Cardinal Health 55154-5374 55154-5374-0 10 BLISTER PACK in 1 BAG (55154-5374-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Jun 8, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Jun 8, 2010TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Jun 8, 2010TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Covington
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US Army
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Deloitte
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