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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 211394


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NDA 211394 describes SIMVASTATIN, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Oxford Pharms, Pharmobedient, Rising, Sun Pharm Inds Ltd, Watson Labs Teva, Yiling, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from twenty-nine 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 suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 211394
Tradename:SIMVASTATIN
Applicant:Yiling
Ingredient:simvastatin
Patents:0
Pharmacology for NDA: 211394
Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors
Medical Subject Heading (MeSH) Categories for 211394
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Suppliers and Packaging for NDA: 211394
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIMVASTATIN simvastatin TABLET;ORAL 211394 ANDA Westminster Pharmaceuticals, LLC 69367-374 69367-374-09 90 TABLET, FILM COATED in 1 BOTTLE (69367-374-09)
SIMVASTATIN simvastatin TABLET;ORAL 211394 ANDA Westminster Pharmaceuticals, LLC 69367-374 69367-374-10 1000 TABLET, FILM COATED in 1 BOTTLE (69367-374-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 27, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 27, 2024TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Nov 27, 2024TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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