CTD Section 1.1.2 Report
Summary
Section Name:
Form FDA 356h: Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
Section Code:
1.1.2
Module Number:
1
Description:
Form contains general information on a product and the applicant of a marketing application (NDA, ANDA, BLA only)
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources