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<NDC>
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83616-107-11
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1 VIAL, SINGLE-DOSE in 1 CARTON (83616-107-11) / 1 mL in 1 VIAL, SINGLE-DOSE (83616-107-01)
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<NDC11Code>
83616-0107-11
</NDC11Code>
<ProductNDC>
83616-107
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<ProductTypeName>
HUMAN PRESCRIPTION DRUG
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<ProprietaryName>
Tudriqev
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<ProprietaryNameSuffix/>
<NonProprietaryName>
Vusolimogene Oderparepvec-wtpg
</NonProprietaryName>
<DosageFormName>
INJECTION, SUSPENSION
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<RouteName>
INTRATUMOR
</RouteName>
<StartMarketingDate>
20260904
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA125827
</ApplicationNumber>
<LabelerName>
Replimune, Inc.
</LabelerName>
<SubstanceName>
VUSOLIMOGENE ODERPAREPVEC
</SubstanceName>
<StrengthNumber>
10000000
</StrengthNumber>
<StrengthUnit>
[PFU]/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-09-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
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<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260904
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>