ABSTRACT
An Abbreviated New Drug Application (ANDA) is specifically designed for an approval of a generic drug product. When data within an ANDA are submitted to the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), Office of Generic Drugs, the applications are reviewed and approved from that division. On approval of the application the applicant may manufacture and market the generic drug product with the purpose of providing consumers with a safe, effective, and low cost alternative of the generic form of a brand name drug.
