How do I find out if a drug is approved? Is there a Web site I can go to?
To find out if a drug is approved by FDA, consumers can use two different Internet sites:
- Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. Drugs@FDA helps consumers find generic equivalents and other possible appropriate alternatives to their approved products as well as the product’s drug label. FDA updates this list every day.
- The FDA "Orange Book" contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). This site is regularly updated and shows the date of the most current update at the top of the page.
If consumers do not have access to the Internet or would like more information, they can call 301-827-4573 or 888-INFO-FDA (1-888-463-6332). Questions can also be submitted by e-mail to email@example.com.
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- Materials from Webinar on Access to Investigational Drugs
- FDA Basics Webinar: "Mini-Sentinel," FDA's New Tool for Monitoring the Safety of FDA-Approved Medical Products
- How FDA Evaluates Regulated Products: Drugs
- FDA Webinar on Prescription Drug Shortages
- FDA Webinar on "Bad Ads" Program
- FDA Basics Webinar on Generic Drugs
- FDA Basics Videos: Tim Coté on Orphan Drugs
- What is an FDA Drug Safety Communication?
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- FDA Basic Video: Interview with John Jenkins on New Drugs (Video)
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- How do I find out if a drug is approved? Is there a Web site I can go to?
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- What is a Warning Letter?
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