CTD Section 1.5.6 Report
Summary
Section Name:
Withdrawal of listed drug
Section Code:
1.5.6
Module Number:
1
Description:
Document in which a sponsor of an approved drug requests the drug be removed from the FDA list of approved drugs because the drug is no longer being marketed
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources