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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

ANDA Submissions –. Refuse to Receive for. Lack of Justification of. Impurity Limits. Guidance for Industry. U.S. Department of Health and Human Services.

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