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Abbreviated New Drug Application (ANDA) | Drug Regulatory Affairs
10:36
YouTubePharma Learn
Abbreviated New Drug Application (ANDA) | Drug Regulatory Affairs
An ANDA is a request to the Food and Drug Administration (FDA) to manufacture and market a generic drug in the United States. The ANDA does not require the applicant to conduct clinical trials. An ANDA-approved drug must be bioequivalent to the brand-name drug. If an ANDA is approved, it is listed in the Orange Book as an FDA-approved medicine
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