Multi-Market Approved Product

**Semantic type:** Manufactured Object

**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."