What exactly is a pre-assigned application number?

A pre-assigned application number is a unique six-digit number, e.g., 012345, assigned to sponsors to enable them identify their application.

This number is required any time a submission is made to an eCTD application.

Before you request a pre-assigned eCTD application number, you need to apply for a secure email with the FDA by contacting SecureEmail@fda.hhs.gov.

Click here for more information on how to obtain the pre-assigned application number.