FDA Updates Refuse-to-Receive Rules for ANDA Submissions
ANDAs that have one major deficiency will automatically be refused, while it takes 10 or more minor deficiencies to derail an application. If a sponsor decides to correct the deficiencies and resubmit the application, it will be considered a new ANDA and require a new GDUFA fee.
http://www.fdanews.com/articles/171439-fda-updates-refuse-to-receive-rules-for-anda-submissions