<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
71288-569-90
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91)
</PackageDescription>
<NDC11Code>
71288-0569-90
</NDC11Code>
<ProductNDC>
71288-569
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Leuprolide Acetate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Leuprolide Acetate
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20240515
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA075471
</ApplicationNumber>
<LabelerName>
Meitheal Pharmaceuticals Inc
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-12
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240515
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>