<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
62450-003-01
</NDCCode>
<PackageDescription>
100 mL in 1 BOTTLE (62450-003-01)
</PackageDescription>
<NDC11Code>
62450-0003-01
</NDC11Code>
<ProductNDC>
62450-003
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Vamorolone
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20231123
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Purna Pharmaceuticals NV
</LabelerName>
<SubstanceName>
VAMOROLONE
</SubstanceName>
<StrengthNumber>
40
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2024-02-10
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
23-NOV-23
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>