<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70710-2183-3
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (70710-2183-3) * 2 mL in 1 VIAL, GLASS (70710-2181-1) * 2.2 mL in 1 VIAL, GLASS (70710-2182-1)
</PackageDescription>
<NDC11Code>
70710-2183-03
</NDC11Code>
<ProductNDC>
70710-2183
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Romidepsin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Romidepsin
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20261101
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA220783
</ApplicationNumber>
<LabelerName>
Zydus Pharmaceuticals USA Inc.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-11-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20261101
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>