Label: ONCOPIG CANCER MODEL- oncopig not applicable

  • Category: RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated May 11, 2023

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  • Cre-inducible Neo-KRASG12D-TP53R167H rDNA construct in the ITPRID1 gene in cross-bred swine

    This is an investigational animal that contains intentional genomic alterations. This animal and any products derived from it are for research purposes only and not for use in humans or as food/feed unless authorization has been granted by the US Food and Drug Administration.FDA package labelFDA package labelFDA package labelFDA package labelFDA package label

  • INGREDIENTS AND APPEARANCE
    ONCOPIG CANCER MODEL 
    oncopig not applicable
    Product Information
    Product TypeRECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABELItem Code (Source)NDC:86150-0001
    Route of AdministrationNOT APPLICABLE
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cre-inducible Neo-KRASG12D-TP53R167H rDNA construct in the ITPRID1 gene in cross-bred swine (UNII: MT2ELV39H4) (Cre-inducible Neo-KRASG12D-TP53R167H rDNA construct in the ITPRID1 gene in cross-bred swine - UNII:MT2ELV39H4) Cre-inducible Neo-KRASG12D-TP53R167H rDNA construct in the ITPRID1 gene in cross-bred swine1 [arb'U]  in 1 [arb'U]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86150-0001-11 [arb'U] in 1 NOT APPLICABLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/09/2021
    Labeler - Sus Clinicals, Inc (117539542)
    Registrant - Sus Clinicals, Inc (117539542)
    Establishment
    NameAddressID/FEIBusiness Operations
    University of Illinois Comparative Genomics Laboratory118385427manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Oak Hill Genetics LLC942380098manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Oak Hill Genetics LLC118974584manufacture
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