ICR Documents

Supporting Statement A Document Date Uploaded 0001 NDAs SSA 2017 Ext.pdf 12/27/2017 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Nonsub Change to add Form FDA 3938 0001 Non sub change to add DMF Form FDA 3938.pdf Justification for No Material/Nonsubstantive Change 01/24/2020 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received