Resources for Information | Approved Drugs
Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998. More about Drugs@FDA
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). The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. In addition, the Orange Book contains therapeutic equivalence evaluations for approved multisource prescription drug products. FAQs on the Orange Book
The “Purple Book” is available both as lists and a searchable, online database that contains information about biological products, including biosimilar and interchangeable biological products, licensed (approved) by the FDA under the Public Health Service (PHS) Act. Currently, the lists contain information about all FDA licensed biological products. The new, searchable database contains information about a limited number of FDA-licensed biological products: licensed biosimilar and interchangeable products, and their reference products.
Additional Resources
- New Drugs at FDA: CDER's New Molecular Entities and New Therapeutic Biological Products
- Drug and Biologic Approval and IND Activity Reports
- First Generic Drug Approvals