CTD Section 1.5.5 Report
Summary
Section Name:
Withdrawal of an unapproved BLA, NDA, ANDA, or Supplement
Section Code:
1.5.5
Module Number:
1
Description:
Document in which the sponsor notifies FDA of their decision to withdraw a submitted (but unapproved) marketing application
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources