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改剂型、改规格的ANDA在USFDA的申报途径
2015.08.07
改剂型、改规格的ANDA在USFDA的申报途径
FD&CA 505
(j) Abbreviated new drug applications
(2)(A) An abbreviated application for a new drug shall contain—
(iii) information to show that the route of administration, the dosage form, and the str...
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