Drugs

Abbreviated New Drug Application (ANDA) Forms and Submission Requirements

This page is a content and format information resource for the generic drug applicants on information on ANDA submission requirements.

ANDA Forms and Electronic Submissions

Requesting an Electronic Common Technical Document (eCTD) Number

  • Step-by-step description of how to request an eCTD number from OGD.
  • You may request a pre-assigned number, ONLY when you are submitting a NEW eCTD ANDA. If you are converting an established ANDA to eCTD, you MUST use the original ANDA application number.
  • If submitting a paper ANDA, do NOT request a pre-assigned number. 
  • If you have any comments or questions, please contact:

    Gerrard Cuthbert
    E-mail: Gerrard.Cuthbert@fda.hhs.gov
    (301) 796-3981

Submissions

  • For paper submissions, postal carrier packages MUST be addressed to the document room (include “ATTN: DOCUMENT ROOM” in the address label) in order for the submission to be processed and tracked. Failure to do so will delay the reviewer’s receipt and review of submission. Please send all submissions (original ANDAs, ANDA amendments, ANDA supplements, and ANDA resubmissions) to the OGD document room address below:
Office of Generic Drugs
Center for Drug Evaluation and Research
Food and Drug Administration
Metro Park North VII
7620 Standish Place
Rockville, MD 20855

Hours of Operation: Monday thru Friday 7:00AM - 6:00PM
Note: We highly recommend that firms consider submitting documents in electronic format.  The OGD document room has limited space and resources to maintain paper documents.
  • For the submission of Form FDA 3500A reports (15-day Alert Reports and Periodic Adverse Drug Experience Reports) to ANDAs, continue to send these to the following address:
Central Document Room
5901-B Ammendale Road
Beltsville MD 20705-1266

Hours of Operation: Monday thru Friday 7:00AM - 6:00PM

 

Contact FDA

240-402-7920
301-595-1147 Fax
Office of Generic Drugs

Immediate Office

10903 New Hampshire Avenue

Silver Spring, MD 20993

Page Last Updated: 09/18/2014
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