About FDA
Are generic drugs the same as brand name drugs?
Federal law requires that companies seeking approval for generic versions of approved drugs must demonstrate that their products are the same as the original brand name drug in terms of
- active ingredients
- strength
- dosage form
- route of administration
- label
In addition, the company must demonstrate that the generic form is absorbed and distributed to the part of the body at which it has its effect at acceptably similar levels to the brand name drug. And all drugs—new or generic, in clinical trials or approved, prescription or over-the-counter—must be manufactured under controlled conditions that assure product quality.
FDA firmly believes that generic drug products that have gone through the approval process can be used with the full expectation that consumers will receive the same benefits from generics as they do from brand name equivalents.
Show all related FDA Basics Questions
- Where can I find information about adverse reactions to a medicine prescribed for my child?
- Where can I find information about medicines prescribed for my child?
- 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?
- What is counterfeit medicine?
- FDA Basic Video: Interview with John Jenkins on New Drugs (Video)
- What are unapproved drugs and why are they on the market?
- How can I stay better informed about drugs? Is there a reliable website FDA recommends?
- How do I discard medicine that I no longer need, do I just throw it in the garbage?
- How do I report a bad reaction to medicine or medication error to FDA?
- Does FDA approve the proprietary names of prescription drugs?
- What does FDA require drug manufacturers to do to prevent contaminated drugs? If contamination occurs, how must they correct the problem?
- How does FDA help consumers when drug shortages happen?
- Does FDA approve the information given out by pharmacies when I pick up my medicine?
- How does FDA decide when a drug is not safe enough to stay on the market?
- How do I find out if a drug is approved? Is there a Web site I can go to?
- What is the approval process for a new prescription drug?
- What is a Warning Letter?
- Can FDA ban direct-to-consumer drug advertising?
How helpful was this information?
