<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
80978-641-01
</NDCCode>
<PackageDescription>
1 mL in 1 VIAL, MULTI-DOSE (80978-641-01)
</PackageDescription>
<NDC11Code>
80978-0641-01
</NDC11Code>
<ProductNDC>
80978-641
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ivra
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Melphalan
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250319
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA217110
</ApplicationNumber>
<LabelerName>
Aqvida GmbH
</LabelerName>
<SubstanceName>
MELPHALAN HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
90
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Alkylating Activity [MoA], Alkylating Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2025-11-14
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250319
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>