CTD Section 1.14.6 Report
Summary
Section Name:
Product labeling for 2253 submissions
Section Code:
1.14.6
Module Number:
1
Description:
If submitting Form 2253, include labeling materials for FDA review in this section
Submission Timing
Include with marketing applications, CDER INDs only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources