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 a Pre-Assigned ANDA Number

  • Step-by-step description of how to request a pre-assigned ANDA number from OGD.
  • You may request a pre-assigned number, ONLY when you are submitting a NEW ANDA. If you are converting an established ANDA to eCTD, you MUST use the original ANDA application number.
  • If you have any comments or questions, please email CDERAPPNUMREQUEST@fda.hhs.gov.

Submissions

The FDA no longer accepts paper ANDA submissions. All ANDA submissions MUST be in eCTD format. eCTD submission sizes 10 GB or less must use the FDA Electronic Submission Gateway (ESG). If an eCTD submission is greater than 10 GB, it may be submitted via physical media (DVD/USB Drive) to the CDER Document Room or via ESG. Please see the guidance for industry “Transmitting Electronic Submissions Using eCTD specifications” for details. This document and other eCTD related guidance and specifications are available on the FDA eCTD website.

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

Back to Top

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: 09/06/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English