About FDA

What are generic drugs and how are they approved?

Generic drugs are chemical equivalents of approved brand name drugs. Since the safety and effectiveness of the brand name drugs have already been shown, generic drugs do not have to be tested for safety and effectiveness, as long as the generic drug is shown to be the same as an already approved drug. Generic drugs are approved under abbreviated new drug applications (ANDAs).

Page Last Updated: 05/12/2016
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