<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
83853-101-01
</NDCCode>
<PackageDescription>
28 PACKET in 1 CARTON (83853-101-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET
</PackageDescription>
<NDC11Code>
83853-0101-01
</NDC11Code>
<ProductNDC>
83853-101
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Aqneursa
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Levacetylleucine
</NonProprietaryName>
<DosageFormName>
GRANULE, FOR SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20240924
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA219132
</ApplicationNumber>
<LabelerName>
IntraBio Inc
</LabelerName>
<SubstanceName>
LEVACETYLLEUCINE
</SubstanceName>
<StrengthNumber>
1000
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Bile Salt Export Pump Inhibitors [MoA], Breast Cancer Resistance Protein Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-01-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240924
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>