<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82090-003-01
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (82090-003-01) / 1 POUCH in 1 KIT / 2 SYRINGE in 1 POUCH / 766.7 mg in 1 SYRINGE
</PackageDescription>
<NDC11Code>
82090-0003-01
</NDC11Code>
<ProductNDC>
82090-003
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Risvan
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Risperidone
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20241201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA214835
</ApplicationNumber>
<LabelerName>
Laboratorios Farmaceuticos Rovi, S.A.
</LabelerName>
<SubstanceName>
RISPERIDONE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/766.7mg
</StrengthUnit>
<Pharm_Classes>
Atypical Antipsychotic [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2024-12-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241201
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>