ONCOPIG CANCER MODEL- oncopig not applicable

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

Drug Labeling and Warnings

Cre-inducible Neo-KRASG12D-TP53R167H rDNA construct in the ITPRID1 gene in cross-bred swine by is a Other medication manufactured, distributed, or labeled by Sus Clinicals, Inc, University of Illinois Comparative Genomics Laboratory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

ONCOPIG CANCER MODEL 
oncopig not applicable

Product Information
Product Type	RECOMBINANT DEOXYRIBONUCLEIC ACID CONSTRUCT LABEL	Item Code (Source)	NDC: 86150-0001
Route of Administration	NOT APPLICABLE

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 swine	1 [arb'U]  in 1 [arb'U]

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86150-0001-1	1 [arb'U] in 1 NOT APPLICABLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/09/2021

Labeler - Sus Clinicals, Inc (117539542)

Registrant - Sus Clinicals, Inc (117539542)

Establishment
Name	Address	ID/FEI	Business Operations
University of Illinois Comparative Genomics Laboratory		118385427	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Oak Hill Genetics LLC		942380098	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Oak Hill Genetics LLC		118974584	manufacture