CTD Section 1.12.12 Report
Summary
Section Name:
Comparison of generic drug and reference listed drug
Section Code:
1.12.12
Module Number:
1
Description:
Document containing information that the generic product is the same as the reference listed product
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources