<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52658-7777-1
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (52658-7777-1) / 2 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
52658-7777-01
</NDC11Code>
<ProductNDC>
52658-7777
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Lymphir
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Denileukin Diftitox-cxdl
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250301
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761312
</ApplicationNumber>
<LabelerName>
Citius Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
DENILEUKIN DIFTITOX
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
ug/2mL
</StrengthUnit>
<Pharm_Classes>
CD25-directed Cytotoxin [EPC], Diphtheria Toxin [CS], Interleukin-2 [CS], Recombinant Fusion Proteins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-03-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250301
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>