CTD Section 1.14.3.1 Report
Summary
Section Name:
Annotated comparison with listed drug
Section Code:
1.14.3.1
Module Number:
1
Description:
This section is where a sponsor of a generic drug application may illustrate how an approved drug label differs from their proposed labeling
Submission Timing
Included with generic drug applications
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources