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LCqingbo

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专业: 合成药物化学

[交流] The basis of submission中的basis该怎样理解？

1.Basis of Submission for an ANDA for a Generic Drug that is the Same as its RLD

When an applicant submits an ANDA for a generic drug that is the same as its RLD, the basis of
submission is the RLD. Accordingly, the name of the RLD, including dosage form and strength,
and its application number should be provided as the basis of submission on Form FDA 356h
(i.e., the form that accompanies regulatory submissions by an applicant) and in the appropriate sections of the ANDA.

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