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 In this section:

                Abbreviated New Drug Application (ANDA)

Abbreviated New Drug Application (ANDA)

                        Generic Drug Development
          Abbreviated New Drug Application (ANDA) Forms and Submission Requirements
          Patent Certifications and Suitability Petitions Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Types of Applications
          Abbreviated New Drug Application (ANDA)
          Generic Drug Review Dashboard ReportAbbreviated New Drug Application (ANDA) Generic Drug Review Dashboard Report
  
  	
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    Print***NOTE:***The quarterly reporting required under GDUFA II section VI(C)(2) of the GDUFA Reauthorization Performance Goals and Enhancements Fiscal Years 2018-2022, supersedes the information provided in the Generic Drug Dashboard Report. The final Generic Drug Review Dashboard Report provides data as of April 1, 2018. The metrics that appeared in the Generic Drug Review Dashboard Report can now be found in the GDUFA II Quarterly Performance report. Additional generic drug program activity metrics are available on the GDUFA Enhanced Accountability and Reporting page.The Office of Generic Drugs (OGD) voluntarily developed the Generic Drug Review Dashboard Report to provide transparency and communication as the agency implemented the Generic Drug User Fee Amendments of 2012 (GDUFA). OGD’s GDUFA commitments are part of our ongoing efforts to make quality, affordable generic medicines available to the American public.Generic Drug Review Dashboard ReportsGeneric Drug Review Dashboard Report as of April 1, 2018Generic Drug Review Dashboard Report as of January 1, 2018The Generic Drug Review Dashboard as of October 1, 2017Generic Drug Review Dashboard Report as of July 1, 2017Generic Drug Review Dashboard Report as of April 1, 2017Generic Drug Review Dashboard Report as of January 1, 2017Generic Drug Review Dashboard Report as of October 1, 2016Generic Drug Review Dashboard Report as of July 1, 2016May 2016 Generic Drug Review Dashboard ReportFebruary 2016 Generic Drug Review Dashboard ReportLearn MoreGeneric DrugsIndustry Resources

                                                                                  Content current as of:
      06/05/2018Abbreviated New Drug Application (ANDA)

          
                        Generic Drug Development
          Abbreviated New Drug Application (ANDA) Forms and Submission Requirements
          Patent Certifications and Suitability Petitions
 
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