<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81165-100-01
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (81165-100-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
81165-0100-01
</NDC11Code>
<ProductNDC>
81165-100
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Letybo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Letibotulinumtoxina-wlbg
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20240730
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761225
</ApplicationNumber>
<LabelerName>
Hugel, Inc.
</LabelerName>
<SubstanceName>
LETIBOTULINUMTOXINA
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
U/1
</StrengthUnit>
<Pharm_Classes>
Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-11-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240730
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>