<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0065-8595-01
</NDCCode>
<PackageDescription>
3 POUCH in 1 CARTON (0065-8595-01) / 5 VIAL in 1 POUCH / .4 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
00065-8595-01
</NDC11Code>
<ProductNDC>
0065-8595
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Tryptyr
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Acoltremon
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
OPHTHALMIC; TOPICAL
</RouteName>
<StartMarketingDate>
20250723
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA217370
</ApplicationNumber>
<LabelerName>
Alcon Laboratories, Inc.
</LabelerName>
<SubstanceName>
ACOLTREMON
</SubstanceName>
<StrengthNumber>
.03
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250723
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
Y
</SamplePackage>
</NDC>