Generic Drug Development
Generic Drug Approvals
FDA regularly updates a listing 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. The database is updated daily.
Generic Drug Regulatory Resources
- Product-Specific Guidances for Generic Drug Development
- Generic Drugs Guidances – under “Topic,” choose “Generic Drugs”
- Laws Enforced by the FDA
- Generic Drug User Fee Amendments (GDUFA)
- Code of Federal Regulations (CFR)
- Federal Register (FR)
- CDER FOIA Electronic Reading Room
Potential applicants are encouraged to contact the FDA Generic Drugs Program with questions at any point in their development and ANDA preparation processes.
If you have specific questions regarding the development of a generic drug product not yet submitted in an abbreviated new drug application (ANDA), please submit a controlled correspondence.
If you have a general question about generic drugs, please email firstname.lastname@example.org.
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