Preferred Label : Cross-labeled Product;
NCIt definition : An investigational drug, device, or biological product packaged separately that, according
to its proposed labeling, is intended for use only with another investigational or
approved individually specified drug, device, or biological product where both are
required to achieve the intended use, indication, or effect. In the case where an
approved product is combined with an investigational product, upon approval of the
cross-labeled product the label of the previously approved product should be modified
to reflect the combination status. (21 CFR 3.2 (e) FAQ);
Alternative definition : CDISC-GLOSS: An investigational drug, device, or biological product packaged separately
that, according to its proposed labeling, is intended for use only with another investigational
or approved individually specified drug, device, or biological product where both
are required to achieve the intended use, indication, or effect. NOTE: In the case
where an approved product is combined with an investigational product, upon approval
of the cross-labeled product the label of the previously approved product should be
modified to reflect the combination status. [After 21 CFR 3.2 (e) FAQ] See also combination
product, single-entity product, co-packaged product.;
NCI Metathesaurus CUI : CL979049;
Origin ID : C165825;
UMLS CUI : C5237466;
Semantic type(s)
- concept_is_in_subset
