<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70709-153-70
</NDCCode>
<PackageDescription>
60 TABLET in 1 BOTTLE (70709-153-70)
</PackageDescription>
<NDC11Code>
70709-0153-70
</NDC11Code>
<ProductNDC>
70709-153
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Phyrago
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dasatinib
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250922
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA216099
</ApplicationNumber>
<LabelerName>
Cycle Pharmaceuticals Ltd
</LabelerName>
<SubstanceName>
DASATINIB
</SubstanceName>
<StrengthNumber>
70
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250922
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>