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U.S. Department of Health and Human Services

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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 druginfo@fda.hhs.gov.

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