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Agenda
Reg Review
ICR
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
Public Comments
Author Name
Comment Document
Author Affiliation
Sponsoring Org.
Type
Category
Date of Comment
Date Comment Received
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An official website of the United States government
The .gov means it's official.
The site is secure.
