FDA’s Nextgen Portal to Submit Pre-Assigned ANDA Number Requests through the CDER

Prospective abbreviated new drug application (ANDA) applicants will be able to submit Pre-Assigned ANDA number requests via the CDER NextGen Portal.

For Applicants with account holder account will be automatically updated with this Pre-Assigned ANDA number request functionality.  To create a new account, go to the CDER NextGen Portal, under the “Sign In” section on the right of the screen, click “Sign Up” (next to “Don’t have an account?”) and follow the instructions.

Benefits of using the Portal for pre-assigned number requests:

  • Ease of Use: Submitting via the Portal is easy-company information can be pre-populated, and all information regarding submissions is in one place
  • Automated confirmation: Portal users can log in, initiate a request, and receive an automated confirmation of the request.
  • Historical record: Portal users can view all submissions at any time. The Portal organizes requests based on submission status to assist with navigating requests.

For more login assistance, please go to: CDER NextGen Portal FAQs

For additional information on submitting pre-assigned application number requests, please visit the Requesting a Pre-Assigned Application number web page.