Potential ANDA applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and application preparation processes.
If you have specific questions regarding the development of a generic drug product not yet submitted in an ANDA, please submit a controlled correspondence.
If you have a general question about generic drugs, please email [email protected].
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.
Additional Generic Drugs Program assistance resources are available at GDUFA Points of Contact.
Office of Generic Drugs
10903 New Hampshire Avenue
Silver Spring, MD 20993
240-402-7920
301-595-1147 Fax
