<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0781-6187-70
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (0781-6187-70) / 10 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
00781-6187-70
</NDC11Code>
<ProductNDC>
0781-6187
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Fml
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fluorometholone
</NonProprietaryName>
<DosageFormName>
SUSPENSION/ DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20260330
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA218819
</ApplicationNumber>
<LabelerName>
Sandoz Inc
</LabelerName>
<SubstanceName>
FLUOROMETHOLONE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-31
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260330
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>