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This document provides statistics and recommendations regarding Abbreviated New Drug Applications (ANDAs) submitted to the FDA. It summarizes submission data from fiscal years 2009-2011, including the number of ANDAs submitted and refused to receive. Common reasons for refusal to receive are listed. The document also provides updates to the ANDA filing review checklist and comments from FDA reviewers regarding improving ANDA submissions.
This document provides statistics and recommendations regarding Abbreviated New Drug Applications (ANDAs) submitted to the FDA. It summarizes submission data from fiscal years 2009-2011, inc…