<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
73657-020-01
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 CARTON (73657-020-01) > 50 mL in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
73657-0020-01
</NDC11Code>
<ProductNDC>
73657-020
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pepaxto
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Melphalan Flufenamide
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20210226
</StartMarketingDate>
<EndMarketingDate>
20220813
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA214383
</ApplicationNumber>
<LabelerName>
Oncopeptides, AB
</LabelerName>
<SubstanceName>
MELPHALAN FLUFENAMIDE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
20
</StrengthNumber>
<StrengthUnit>
mg/50mL
</StrengthUnit>
<Pharm_Classes>
Alkylating Activity [MoA], Alkylating Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2022-08-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20210226
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20220813
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>