<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
35573-447-30
</NDCCode>
<PackageDescription>
30 TABLET, FILM COATED in 1 BOTTLE (35573-447-30)
</PackageDescription>
<NDC11Code>
35573-0447-30
</NDC11Code>
<ProductNDC>
35573-447
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Leflunomide
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Leflunomide
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20220103
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA213497
</ApplicationNumber>
<LabelerName>
Burel Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
LEFLUNOMIDE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Antirheumatic Agent [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220103
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>