Drugs@FDA
Find information about most FDA-approved prescription, generic, and over-the-counter drug products.
Drugs
The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States
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FDA Actions to Support and Strengthen Domestic Drug Manufacturing
The FDA is taking decisive steps to help strengthen U.S. pharmaceutical manufacturing, improve supply chain resilience, and ensure Americans have reliable access to safe, effective, high-quality medicines.
Learn moreNews
FDA approves drug to treat HIV infection in newborns
Previously approved for adults and children older than four weeks
New product-specific guidances to facilitate generic drug development
This batch of 55 PSGs contains 24 new and 31 revised
FDA approves new drug treating narcolepsy type 1
First drug targeting narcolepsy type 1's full symptom profile and underlying cause
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Upcoming Drug-related Events
Contact Us
Division of Drug Information
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993
Toll Free
(855) 543-3784
(301) 796-3400
Hours Available
Center for Drug Evaluation and Research (CDER)
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@FDAdrugs
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