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                Generic Drugs

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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

                                                                                  Content current as of:
      04/21/2023
              
              
Regulated Product(s)
		 DrugsGeneric Drugs

          
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