<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63323-762-57
</NDCCode>
<PackageDescription>
5 BOX in 1 CARTON (63323-762-57) > 1 VIAL in 1 BOX > 4 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
63323-0762-57
</NDC11Code>
<ProductNDC>
63323-762
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Topotecan Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Topotecan Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20150916
</StartMarketingDate>
<EndMarketingDate>
20160318
</EndMarketingDate>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA091376
</ApplicationNumber>
<LabelerName>
Fresenius Kabi USA, LLC
</LabelerName>
<SubstanceName>
TOPOTECAN HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
4
</StrengthNumber>
<StrengthUnit>
mg/4mL
</StrengthUnit>
<Pharm_Classes>
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2016-03-25
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>