CTD Section 1.14.3.3 Report
Summary
Section Name:
Labeling text for reference listed drug
Section Code:
1.14.3.3
Module Number:
1
Description:
This section contains the labeling for reference listed drug (drug that serves as a reference standard for bioequivalence testing of generic drugs)
Submission Timing
Included with generic drug applications
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources