ANDA Checklist for Completeness and Acceptability (Quarter 4, 2013) (PDF - 105KB) 
The Office of Generic Drugs has revised the regulatory filing checklist for 2011 to enhance the ANDA review process. The attached PDF is a copy of the regulatory filing checklist with updates hi-lited in orange (with each posting, the prior posted revision(s) will revert back to black to emphasize the new updates). The regulatory filing checklist will be reviewed on a quarterly basis (calendar year) and updated on an as needed basis. Please contact Johnny Young (johnny.young@FDA.HHS.Gov) and or Iain Margand (Iain.Margand@FDA.HHS.Gov) from the Regulatory Support Branch should you have any questions.