CTD Section 1.12.11 Report
Summary
Section Name:
ANDA basis for submission statement
Section Code:
1.12.11
Module Number:
1
Description:
Statement to identify the reference listed drug product that is the basis of the ANDA submission
Submission Timing
Not applicable to gene therapies
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources