CTD Section 1.1.4 Report
Summary
Section Name:
Form FDA 2252: Transmittal of Annual Reports for Drugs and Biologics for Human Use
Section Code:
1.1.4
Module Number:
1
Description:
Form that accompanies annual submissions for NDAs, BLAs, ANDAs
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources