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ANDA REGULATORY APPROVAL PROCESS ANDA REGULATORY APPROVAL PROCESS

ANDA REGULATORY APPROVAL PROCESS - PowerPoint Presentation

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Uploaded On 2019-01-29

ANDA REGULATORY APPROVAL PROCESS - PPT Presentation

Abbreviated new drug application ANDA These are submitted to the FDAs CDER center for drug evaluation and research The Office of the Generic drugs OGD is located within the CDER under the office of pharmaceutical science to obtain approval to market a generic drug product ID: 748710

drug review anda labeling review drug labeling anda applicant process generic application approval product letter team amp chemistry bioequivalence

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