Changes to anapprovedNDA or ANDA(工艺变更对于申报影响).pdfVIP

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Changes to anapprovedNDA or ANDA(工艺变更对于申报影响).pdf

Guidance for Industry Changes to an Approved NDA or ANDA U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April

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