Patent certification options
Brand vs first ANDA filer Activity Summary
NDA Patent and Data Exclusivity
Multiple ANDAs http://www.fda.gov/CDER/GUIDANCE/5710fnl.pdf
GMP, DMF, active pharmaceutical ingredients (APIs), ドラッグマスターファイル,原薬 原料藥, generic drug, 學名藥, 仿制藥, biogeneric drug
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