MedicationsCâu 17 / 100
A product carries a 'BX' code in the Orange Book. What does this indicate?
a.The product is fully bioequivalent to the reference listed drug
b.The product is available only as a brand name
c.Available data are insufficient to establish therapeutic equivalence
d.The product has been withdrawn from the market for safety reasons
Giải thích
Codes beginning with B indicate products the FDA does not consider therapeutically equivalent, and BX specifically means the data are insufficient to determine equivalence, so automatic substitution is not appropriate. AB is the code for demonstrated equivalence, and market withdrawal is handled through separate FDA actions, not the equivalence code.
Trích dẫn luật: FDALuyện miễn phí toàn bộ 100 câu hỏi — không cần đăng ký.
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