<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83709-001-90
</NDCCode>
<PackageDescription>
1 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
83709-0001-90
</NDC11Code>
<ProductNDC>
83709-001
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Xtoro
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Finafloxacin
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
AURICULAR (OTIC)
</RouteName>
<StartMarketingDate>
20260501
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA206307
</ApplicationNumber>
<LabelerName>
Fonseca Biosciences, LLC
</LabelerName>
<SubstanceName>
FINAFLOXACIN
</SubstanceName>
<StrengthNumber>
3
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Quinolone Antimicrobial [EPC], Quinolones [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-05-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260501
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
Y
</SamplePackage>
</NDC>