<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65044-4441-1
</NDCCode>
<PackageDescription>
10 VIAL in 1 PACKAGE (65044-4441-1) > 5 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
65044-4441-01
</NDC11Code>
<ProductNDC>
65044-4441
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Kinevac
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sincalide
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20070905
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT
</MarketingCategoryName>
<ApplicationNumber>
NDA017697
</ApplicationNumber>
<LabelerName>
Jubilant HollisterStier LLC
</LabelerName>
<SubstanceName>
SINCALIDE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
ug/5mL
</StrengthUnit>
<Pharm_Classes>
Cholecystokinin [Chemical/Ingredient],Cholecystokinin Analog [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-12-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20181231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>