New feature available! Submit Pre-Assigned ANDA number requests through the CDER NextGen Portal

New feature available! Submit Pre-Assigned ANDA number requests through the CDER NextGen Portal

Effective June 17, 2019, prospective abbreviated new drug application (ANDA) applicants can now submit Pre-Assigned ANDA number requests via the CDER NextGen Portal. 

If you already have a CDER NextGen Portal account, your account will be automatically updated with the 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.

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

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: Site users can log in, initiate a request, and receive an automated confirmation of submission.
• Historical record: Site users can view all submissions at any time. The Portal organizes requests based on submission status to assist with navigating requests.

For technical support, please email CDER Platform Support at edmsupport@fda.hhs.gov. 

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