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  1. Generic Drugs

Industry Resources

April 9-10: SBIA | Generic Drugs Forum (GDF) 2025
See the Agenda and Register Today!

Get the latest on the development and approval of safe, effective, and high-quality generic medicines. FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs will offer unparalleled insights and guidance.

Join us in person at the Bethesda North Marriott Hotel & Conference Center, located at
5701 Marinelli Road in Rockville, MD.

FDA provides information to assist industry in the development of generic drugs and submission of abbreviated new drug applications (ANDAs). This section includes links to summary tables used in ANDA submission, common FDA forms, guidances, and other related information.

Abbreviated New Drug Applications (ANDAs)
An overview of generic drug applications, resources for ANDA submission, and information on the review process

Generic Drug Development
Information to assist in the development of generic drug products submitted for FDA review

ANDA Forms and Submission Requirements
Summary tables, application forms, question-based review, and other resources related to ANDA submissions

Patent Certifications and Suitability Petitions
Information and resources related to patents, Paragraph IV certifications, and suitability petitions

Global Generic Drug Affairs
Information about OGD’s efforts to support regulatory activities through international engagements with industry, international regulatory agencies, scientific community, and the public

Who to Contact 
Contact information for questions about the generic drugs program, ANDAs, and GDUFA

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