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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 078103


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NDA 078103 describes SIMVASTATIN, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Mylan Pharms Inc, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, and Zydus Pharms Usa, and is included in sixteen NDAs. It is available from thirty-five 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 078103
Tradename:SIMVASTATIN
Applicant:Lupin
Ingredient:simvastatin
Patents:0
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, LLC dba Vangard Labs 0615-7992 0615-7992-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-05)
SIMVASTATIN simvastatin TABLET;ORAL 078103 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-7992 0615-7992-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-39)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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