<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72205-239-63
</NDCCode>
<PackageDescription>
28 CAPSULE in 1 BLISTER PACK (72205-239-63)
</PackageDescription>
<NDC11Code>
72205-0239-63
</NDC11Code>
<ProductNDC>
72205-239
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Nilotinib
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nilotinib
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251119
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA218544
</ApplicationNumber>
<LabelerName>
Novadoz Pharmaceuticals LLC
</LabelerName>
<SubstanceName>
NILOTINIB
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-21
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251120
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>