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Last Updated: August 10, 2020

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Details for New Drug Application (NDA): 077837

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NDA 077837 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 thirty-six 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-eight suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 077837
Tradename:SIMVASTATIN
Applicant:Zydus Pharms Usa
Ingredient:simvastatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077837
Suppliers and Packaging for NDA: 077837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 077837 ANDA McKesson Corporation dba SKY Packaging 63739-435 63739-435-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-435-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
SIMVASTATIN simvastatin TABLET;ORAL 077837 ANDA McKesson Corporation dba SKY Packaging 63739-436 63739-436-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-436-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK

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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