CTD Section 1.14.2.2 Report
Summary
Section Name:
Final package insert (package inserts, patient information, Medication guides)
Section Code:
1.14.2.2
Module Number:
1
Description:
Images/text of the final, approved version of the package insert is submitted in this section
Submission Timing
Marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources