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# CDER NextGen Portal Pre-assigned ANDA Numbers
- URL: https://www.fdaweb.com/cder-nextgen-portal-pre-assigned-anda-numbers/
- Published: 2019-06-06T12:00:00.000Z
- Updated: 2026-09-15T01:31:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144272

FDA has announced that later this month generic drug applicants will be able to submit pre-assigned ANDA number requests through [CDER’s NextGen Portal](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=SBIA%3A%20Coming%20soon%21%20Submit%20Pre-Assigned%20ANDA%20number%20requests%20through%20the%20CDER%20NextGen%20Portal&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=8242&elqTrackId=8245C7BEF333F2B1574CF9ED91086179&elq=3bfcb0829f764b4781f39e34f5d221c1&elqaid=8282&elqat=1). For sponsors already having a [CDER NextGen Portal ](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=SBIA%3A%20Coming%20soon%21%20Submit%20Pre-Assigned%20ANDA%20number%20requests%20through%20the%20CDER%20NextGen%20Portal&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=8242&elqTrackId=50BACB2F445B0C62E0DBC28B798EC95D&elq=3bfcb0829f764b4781f39e34f5d221c1&elqaid=8282&elqat=1)account, the account will be automatically updated with this pre-assigned ANDA number request functionality. To create a new account, go to the [CDER NextGen Portal](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=SBIA%3A%20Coming%20soon%21%20Submit%20Pre-Assigned%20ANDA%20number%20requests%20through%20the%20CDER%20NextGen%20Portal&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=8242&elqTrackId=5E256535F2AEDF240B79B1F6750CBA63&elq=3bfcb0829f764b4781f39e34f5d221c1&elqaid=8282&elqat=1) and 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, go to: [CDER NextGen Portal FAQs](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=SBIA%3A%20Coming%20soon%21%20Submit%20Pre-Assigned%20ANDA%20number%20requests%20through%20the%20CDER%20NextGen%20Portal&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=8241&elqTrackId=419AE9BF7D4F9C2298FAB2DF2D6E04ED&elq=3bfcb0829f764b4781f39e34f5d221c1&elqaid=8282&elqat=1). For technical support, email CDER Platform Support at edmsupport@fda.hhs.gov.

FDA has outlined the benefits of using the portal for pre-assigned number requests. They are: 

- Ease of Use: Submitting via the portal is described as 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.