<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
67184-0618-2
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (67184-0618-2) * 15 mL in 1 VIAL, SINGLE-DOSE (67184-0616-1) * 10 mL in 1 VIAL, SINGLE-USE (67184-0617-1)
</PackageDescription>
<NDC11Code>
67184-0618-02
</NDC11Code>
<ProductNDC>
67184-0618
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Melphalan Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Melphalan Hydrochloride
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20231218
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA211463
</ApplicationNumber>
<LabelerName>
Qilu Pharmaceutical Co., Ltd.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-07-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20231218
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>