ICR Documents

Supporting Statement A Document Date Uploaded SUPPORTING STATEMENT 0001 FINAL 9-10-14.doc 09/10/2014 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Application for FDA Approval to Market a New Drug - 0910-0001 Justification Memo for 83C Change Request 2-24-15.doc Justification for No Material/Nonsubstantive Change 02/24/2015 Justification Memorandum for 83-I Change Request OMB Justification Memorandum 0001 for 83-I chg request 1-19-2016.docx Justification for No Material/Nonsubstantive Change 01/19/2016 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received