<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
12522-3331-2
</NDCCode>
<PackageDescription>
16 KIT in 1 BOX (12522-3331-2) / 2 DOSE PACK in 1 KIT / 2 BLISTER PACK in 1 DOSE PACK / 14 TABLET, FILM COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
12522-3331-02
</NDC11Code>
<ProductNDC>
12522-3331
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Rilzabrutinib
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20250829
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Sanofi S.r.l.
</LabelerName>
<SubstanceName>
RILZABRUTINIB
</SubstanceName>
<StrengthNumber>
400
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-08-29
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
29-AUG-25
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>