CTD Section 1.18.1 Report
Summary
Section Name:
Proprietary names
Section Code:
1.18.1
Module Number:
1
Description:
This section is where a sponsor may submit the proposed proprietary name of their drug product, but final approval occurs as part of the approval of the marketing application
Submission Timing
At any point up to and including marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources