<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72851-100-01
</NDCCode>
<PackageDescription>
1 SYRINGE in 1 CARTON (72851-100-01) / .3 g in 1 SYRINGE
</PackageDescription>
<NDC11Code>
72851-0100-01
</NDC11Code>
<ProductNDC>
72851-100
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Camcevi Etm
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Leuprolide
</NonProprietaryName>
<DosageFormName>
INJECTION, EMULSION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20261031
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA219745
</ApplicationNumber>
<LabelerName>
Foresee Pharmaceuticals Co., Ltd.
</LabelerName>
<SubstanceName>
LEUPROLIDE MESYLATE
</SubstanceName>
<StrengthNumber>
21
</StrengthNumber>
<StrengthUnit>
mg/.3g
</StrengthUnit>
<Pharm_Classes>
Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-11-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20261031
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>