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What are FDA approved drugs?

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.

What is the FDA Orange Book?

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.

What is the purpose of the Orange Book?

The FDA’s Orange Book is a list of drugs that are approved by the agency as safe and effective. When a brand pharmaceutical company lists a drug patent in the book it automatically triggers a legal stay that blocks the introduction of competing versions for up to 30 months.

How can errors or discrepancies in the approved drug products data files be reported?

If you wish to report an error or discrepancy in drug data, please send a brief description of the problem to: [email protected] Please send general questions related to the drug data in these files to the Center for Drug Evaluation and Research, Division of Drug Information: [email protected]


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