Generic Drug Development
Generic Drug Approvals
FDA regularly updates its lists of first generic drug approvals and competitive generic therapy approvals. To view all generic drug approvals and tentative approvals, use the “Drug Approval Reports by Month” feature on Drugs@FDA and select “Original Abbreviated New Drug Approvals (ANDAs) by Month” for generic drug approvals or “Tentative Approvals by Month” for tentative approvals. This database is updated daily.
Generic Drug Regulatory Resources
- Product-Specific Guidances for Generic Drug Development
- Generic Drugs Guidances – under “Topic,” choose “Generic Drugs”
- Generic Drug User Fee Amendments (GDUFA)
- Patent Certifications and Suitability Petitions
- CDER FOIA Electronic Reading Room
- Laws Enforced by the FDA
- Code of Federal Regulations (CFR)
- Federal Register (FR)
Contact FDA
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 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.
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