Preferred Label : Multi-Market Approved Product;
NCIt definition : An FDA-approved prescription drug or FDA-licensed biological product, or a combination
product approved in an NDA or BLA, originally authorized for marketing in a foreign
country, and imported for marketing in the U.S. following the recommendations in FDA
Guidance: Importation of Certain FDA-Approved Human Prescription Drugs, Including
Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal
Food, Drug, and Cosmetic Act.;
NCI Metathesaurus CUI : CL1412760;
Origin ID : C175238;
UMLS CUI : C5446364;
Semantic type(s)
- concept_is_in_subset
