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Still submitting paper ANDA applications?

Experience that shows electronic filing of NDA’s, IND’s and ANDA’s helps speed up the review and approval of these applications. Perhaps because of the software cost and extensive training needed some companies still submit paper applications. Effective today, August 1, 2010, the address to submit the paper ANDA is:

Office of Generic Drugs (HFD—600)
Center for Drug Evaluation and Research, Food and Drug Administration
Metro Park North VII, 7620 Standish Pl.
Rockville, MD 20855.

This address is also used when mailing IND’s that are used to support ANDA’s.

At Camargo, we advise clients to submit electronic applications whenever possible. We have the software and training needed to accomplish this task. We have set up an document management system that allows each client to securely view all of their documents and to view the eCTD submission at any time.