CTD Section 1.14.3.2 Report
Summary
Section Name:
Approved labeling text for listed drug
Section Code:
1.14.3.2
Module Number:
1
Description:
This section contains the original label text for listed (approved) drugs
Submission Timing
Included with generic drug applications
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources