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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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pharmaceutical manufacturing

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.

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Consumer Contact Information Drug Alerts and Statements What's New Related to Drugs

Search our databases:

Drugs@FDA

Find information about most FDA-approved prescription, generic, and over-the-counter drug products.

Drug Shortages

Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations.

Orange Book

The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness.

News

Woman with eyes closed

FDA Approves New Drug Treating Narcolepsy Type 1

First drug targeting narcolepsy type 1's full symptom profile and underlying cause
Image of an older woman taking a pill

First nonprescription combination of acetaminophen and naproxen sodium

For 12-hour pain relief
Graphic with a white background and blue text overlay. Text reads Drug Approval First Generic and features image outlines of a dropper, medicine bottle and other items.
First Generic Graphic

FDA approves first generic treatment for metastatic non-small cell lung cancer

Approval is a milestone in expanding patient access to an important oncology treatment

Navigate the Drugs Section

Generics

Ensuring access to safe, affordable, and effective generic drugs

Center

Upcoming Drug-related Events

Priority Areas & Initiatives

Opioids

Reducing the impact of opioid misuse and abuse

Warning Letters

Warning and Notice of Violation Letters to Pharmaceutical Companies

Guidances

FDA's current thinking on drug development and review activities

Drug Shortages

Search the database, learn about root causes and potential solutions

Resources

Information for consumers, health professionals, and industry

Contact Us

Division of Drug Information
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993

druginfo@fda.hhs.gov

Toll Free
(855) 543-3784
(301) 796-3400

Hours Available

Center for Drug Evaluation and Research (CDER)

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@FDA_Drug_Info

Your source for the latest drug information.
Know the moment it happens.

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