CTD Section 3.2.P.1 Report
Summary
Section Name:
Description and Composition of the Drug Product
Section Code:
3.2.P.1
Module Number:
3
Description:
Provide a complete description of the drug product: dosage form, list of components and excipients, amount of each component, and purpose of each component
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources