<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
60505-6423-0
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-USE in 1 CARTON (60505-6423-0) / 20 mL in 1 VIAL, SINGLE-USE
</PackageDescription>
<NDC11Code>
60505-6423-00
</NDC11Code>
<ProductNDC>
60505-6423
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Evdi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Trabectedin
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION, CONCENTRATE
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260630
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA220837
</ApplicationNumber>
<LabelerName>
Apotex Corp.
</LabelerName>
<SubstanceName>
TRABECTEDIN
</SubstanceName>
<StrengthNumber>
.05
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Alkylating Activity [MoA], Alkylating Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260630
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>