<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
62327-444-44
</NDCCode>
<PackageDescription>
4 VIAL, GLASS in 1 BOX (62327-444-44) / 50 mL in 1 VIAL, GLASS (62327-444-04)
</PackageDescription>
<NDC11Code>
62327-0444-44
</NDC11Code>
<ProductNDC>
62327-444
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Steritalc
</ProprietaryName>
<ProprietaryNameSuffix>
4g
</ProprietaryNameSuffix>
<NonProprietaryName>
Talc
</NonProprietaryName>
<DosageFormName>
POWDER
</DosageFormName>
<RouteName>
INTRAPLEURAL
</RouteName>
<StartMarketingDate>
20170801
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA205555
</ApplicationNumber>
<LabelerName>
Novatech SA
</LabelerName>
<SubstanceName>
TALC
</SubstanceName>
<StrengthNumber>
4
</StrengthNumber>
<StrengthUnit>
g/50mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-26
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20170801
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>