<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
66435-301-51
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-USE in 1 CARTON (66435-301-51) > 50 mg in 1 VIAL, SINGLE-USE
</PackageDescription>
<NDC11Code>
66435-0301-51
</NDC11Code>
<ProductNDC>
66435-301
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Amphotec
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Amphotericin B
</NonProprietaryName>
<DosageFormName>
INJECTION, LIPID COMPLEX
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20050520
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA050729
</ApplicationNumber>
<LabelerName>
Kadmon Pharmaceuticals LLC
</LabelerName>
<SubstanceName>
AMPHOTERICIN B
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
mg/50mg
</StrengthUnit>
<Pharm_Classes>
Lipid-based Polyene Antifungal [EPC],Polyene Antifungal [EPC],Polyenes [Chemical/Ingredient]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2015-12-25
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>