CTD Section 1.5.7 Report
Summary
Section Name:
Withdrawal of approval of an application or revocation of license
Section Code:
1.5.7
Module Number:
1
Description:
Document in which the sponsor notifies FDA of their decision to withdraw an approved marketing application (usually due to the desire to discontinue manufacturing)
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources