CTD Section 3.2.P.3.2 Report
Summary
Section Name:
Batch Formula
Section Code:
3.2.P.3.2
Module Number:
3
Description:
Provide a batch formula (i.e., a list of all components of the dosage form, and the amount needed to make 1 batch). Include references to quality standards
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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