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Serving leading biopharmaceutical companies globally:

Accenture
Dow
Citi
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Cantor Fitzgerald
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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077752

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NDA 077752 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: 077752

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

Pharmacology for NDA: 077752

Suppliers and Packaging for NDA: 077752

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN
simvastatin
TABLET;ORAL 077752 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6579 0615-6579-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-6579-39)
SIMVASTATIN
simvastatin
TABLET;ORAL 077752 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6580 0615-6580-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-6580-39)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Dec 20, 2006TE:ABRLD:No


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