<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
47335-108-86
</NDCCode>
<PackageDescription>
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)
</PackageDescription>
<NDC11Code>
47335-0108-86
</NDC11Code>
<ProductNDC>
47335-108
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Leqselvi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Deuruxolitinib Phosphate
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250625
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA217900
</ApplicationNumber>
<LabelerName>
Sun Pharmaceutical Industries, Inc.
</LabelerName>
<SubstanceName>
DEURUXOLITINIB PHOSPHATE
</SubstanceName>
<StrengthNumber>
8
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Bile Salt Export Pump Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250625
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>