<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
59676-225-28
</NDCCode>
<PackageDescription>
28 CAPSULE in 1 BOTTLE (59676-225-28)
</PackageDescription>
<NDC11Code>
59676-0225-28
</NDC11Code>
<ProductNDC>
59676-225
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Olysio
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Simeprevir
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20131122
</StartMarketingDate>
<EndMarketingDate>
20180525
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA205123
</ApplicationNumber>
<LabelerName>
Janssen Products LP
</LabelerName>
<SubstanceName>
SIMEPREVIR
</SubstanceName>
<StrengthNumber>
150
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Hepatitis C Virus NS3/4A Protease Inhibitor [EPC],HCV NS3/4A Protease Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2018-05-29
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20131122
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20180525
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>