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Abbreviated New Drug Application - Wikipedia 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)
Abbreviated New Drug Application (ANDA) Approval Process ANDA product labeling must have the same labeling as the RLD, except for differences permitted under the FD C Act (e g , inactive ingredients and packaging configuration)
Search | FDA Application (NDA) and Abbreviated New Drug Application (ANDA) for CBER-Regulated Products …