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.

Electronic Submissions Gateway-New Ticketing Interface

ESG will introduce a web interface to submit and access tickets to all ESG users. This new web interface will allow ESG users to submit tickets, view ticket updates, view the history of all tickets (including closed tickets), and access FAQs based on the ticket Request Type.
1. ESG users may continue to send emails to esghelpdesk@fda.hhs.gov to create tickets and receive response from ESG Help Desk.
2. ESG users may also submit tickets directly to the FDA via https://esghelpdesk.fda.gov.
3. Sending an email to esghelpdesk@fda.hhs.gov automatically creates a new account for each “from” email address. If you have previously communicated with esghelpdesk@fda.hhs.gov then your account already exists in the system and you do not need to send another email to create account.]

For further information please refer:
https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm