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ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to ethrower on DSK3G9T082PROD with NOTICES VerDate Sep<11>2014 20:03 Dec 11, 2017 gain approval of a new drug noroxin application The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U .
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