Use CDER Direct NextGen Collaboration Portal to Submit Approved ANDA List

Electronic Submission of approved ANDAs now available through CDER Direct NextGen Collaboration Portal

As of October 1, 2018, generic drug applicants and their affiliates, or an authorized representative, can submit a list of their approved ANDAs to the FDA for the remainder of GDUFA II (2020-2022), through the CDER Direct NextGen Collaboration Portal. Submissions are due by April 1 of the year prior to the fiscal year they reflect. For example, submissions for FY2020 are due by April 1, 2019.

Submitting this information electronically will streamline the process and facilitate two-way communication between applicants and the Office of Management at the FDA.  

To submit your list of approved ANDAs for fiscal years 2020-2022, you must first register for a CDER Direct NextGen Collaboration Portal account at  https://edm.fda.gov.

For more information, including general questions, or to request a login, login instructions, and contact information, visit the CDER Direct NextGen Collaboration Portal FAQs.