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Serving 500+ biopharmaceutical companies globally:

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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078103

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NDA 078103 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, Micro Labs Ltd, 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-one 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-two suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

Summary for NDA: 078103

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 0615-7992-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7992-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK
SIMVASTATIN
simvastatin
TABLET;ORAL 078103 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7992 0615-7992-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-39)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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