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  1. Generic Drugs

Industry Resources

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Science & Research Learn about generic drug regulatory science at CDER

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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