Drugs

Abbreviated New Drug Application (ANDA) Forms and Submission Requirements

The FDA aspires to assist applicants in developing abbreviated new drug applications (ANDAs). To facilitate the development of an ANDA, agency provides the following resources on ANDA forms and submission requirements.

Please note: Information to assist in the development of generic drug products submitted for FDA review is available in Generic Drug Development.

Contact FDA

Potential applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and ANDA preparation processes.

For inquiries related to ANDAs pending filing review and the status of pending suitability petitions, please email ANDAFiling@fda.hhs.gov.

If you have specific questions regarding the development of a generic drug product not yet submitted in an abbreviated new drug application (ANDA), please submit a controlled correspondence by email to genericdrugs@fda.hhs.gov.

If you have a general question about generic drugs, please email druginfo@fda.hhs.gov.

If you have a question regarding an ANDA for which you are the applicant or authorized representative, please contact the regulatory project manager assigned to the application.

Office of Generic Drugs
10903 New Hampshire Avenue
Silver Spring, MD 20993
240-402-7920
301-595-1147 Fax

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Page Last Updated: 11/28/2017
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