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並前往https://www.fda.gov/files/drugs/published/ANDA-Submissions-%E2%80%94-Refuse-to-Receive-for-Lack-of-Justification-of-Impurity-Limits.pdf

Refuse to Receive for Lack of Justification of Impurity Limits

Impurity Limits. Guidance for Industry. Additional copies are available from: Office of Communications. Division of Drug Information, WO51, Room 2201.

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