ICR Documents

Supporting Statement A Document Date Uploaded 0297 PDUFA SSA 2022 Rev.docx 02/23/2022 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded 0297 Non Substantive Change Request 0297 PDUFA Non sub to include refund waiver reduction requests AUG 2020.pdf Justification for No Material/Nonsubstantive Change 08/01/2020 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received