<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70710-1508-8
</NDCCode>
<PackageDescription>
4 BLISTER PACK in 1 CARTON (70710-1508-8) / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (70710-1508-7)
</PackageDescription>
<NDC11Code>
70710-1508-08
</NDC11Code>
<ProductNDC>
70710-1508
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Bosentan
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Bosentan
</NonProprietaryName>
<DosageFormName>
TABLET, FOR SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260217
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA213981
</ApplicationNumber>
<LabelerName>
Zydus Pharmaceuticals USA Inc.
</LabelerName>
<SubstanceName>
BOSENTAN
</SubstanceName>
<StrengthNumber>
32
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260217
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>