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 DRAFT Form FDA 3331a R3 Form FDA 3331a DRAFT FEB 2020.pdf Supplementary Document 02/19/2020 Change Request for FDA 3331a 0001 Non sub Change Form 3331a update.pdf Justification for No Material/Nonsubstantive Change 02/19/2020 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received