<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
73473-308-50
</NDCCode>
<PackageDescription>
1 BOTTLE, PUMP in 1 CARTON (73473-308-50) / 50 g in 1 BOTTLE, PUMP
</PackageDescription>
<NDC11Code>
73473-0308-50
</NDC11Code>
<ProductNDC>
73473-308
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Estradiol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Estradiol
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260128
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA216160
</ApplicationNumber>
<LabelerName>
Solaris Pharma Corporation
</LabelerName>
<SubstanceName>
ESTRADIOL
</SubstanceName>
<StrengthNumber>
.75
</StrengthNumber>
<StrengthUnit>
mg/1.25g
</StrengthUnit>
<Pharm_Classes>
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-29
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260128
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>