<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
15370-220-99
</NDCCode>
<PackageDescription>
1 POUCH in 1 CARTON (15370-220-99) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .17 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
15370-0220-99
</NDC11Code>
<ProductNDC>
15370-220
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Clotic (clotrimazole) Otic Solution
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Clotrimazole
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
AURICULAR (OTIC)
</RouteName>
<StartMarketingDate>
20260219
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA217628
</ApplicationNumber>
<LabelerName>
Carwin Pharmaceutical Associates, LLC
</LabelerName>
<SubstanceName>
CLOTRIMAZOLE
</SubstanceName>
<StrengthNumber>
1.7
</StrengthNumber>
<StrengthUnit>
mg/.17mL
</StrengthUnit>
<Pharm_Classes>
Azole Antifungal [EPC], Azoles [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260219
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
Y
</SamplePackage>
</NDC>