<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72205-198-01
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (72205-198-01) * 3 mL in 1 VIAL (72205-196-01) * 30 mL in 1 VIAL, SINGLE-DOSE (72205-197-01)
</PackageDescription>
<NDC11Code>
72205-0198-01
</NDC11Code>
<ProductNDC>
72205-198
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Carmustine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Carmustine
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20230511
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214814
</ApplicationNumber>
<LabelerName>
Novadoz Pharmaceuticals LLC
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-11-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20231123
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>