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Abbreviated New Drug Application - Wikipedia An Abbreviated New Drug Application (ANDA) is an application for a U S generic drug approval for an existing licensed medication or approved drug The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product
Abbreviated New Drug Applications (ANDA) Explained: A Quick-Guide An Abbreviated New Drug Application (ANDA) is a submission to the FDA for the approval of generic drugs, demonstrating that the proposed drug is equivalent in safety, efficacy, and quality to a previously approved reference-listed drug (RLD)
What Is ANDA in Pharmaceuticals? A Comprehensive Overview An ANDA is the primary route for obtaining FDA authorization for generic medications in the United States It differs from a New Drug Application (NDA) by streamlining the process to focus on demonstrating bioequivalence to a brand-name drug