FDA RESOURCES

• DailyMed: DailyMed is a website managed by the National Library of Medicine (NLM). The website offers up-to-date information about prescription drugs, including label information, inactive ingredients, tablet shape, and packaging. 

• Drugs@FDA: Drugs@FDA is a website managed by the U.S. Food and Drug Administration (FDA) and provides information on drugs they have approved such as drug approval history, labeling, and safety. Users can search for drug information by various criteria, such as drug name, active ingredient, or application number. 

• Orange Book: The Orange Book is a publication of the FDA that lists drug products approved on the basis of safety and effectiveness. It includes information about patents, exclusivity, and therapeutic equivalence evaluations. 

• OGD Bioequivalence Recommendations for Specific Products: The Office of Generic Drugs (OGD) provides recommendations for bioequivalence studies for specific drug products, which can be found on the FDA website. 

• Inactive Ingredient Database (IID): The Inactive Ingredient Database (IID) is a resource provided by the FDA that contains information on inactive ingredients present in FDA-approved drug products. The database allows users to search for specific inactive ingredients, view the products in which they are used, and access information on their safety and toxicity. The IID is regularly updated and can be a valuable tool for researchers, healthcare professionals, and patients. 

• Dissolution Methods Database: The Dissolution Methods Database is a resource provided by the FDA that contains information on dissolution methods used for drug products. The database includes methods that have been submitted to the FDA by pharmaceutical companies for approval and may be used by manufacturers as a reference when developing their own dissolution methods. It is a valuable tool for ensuring consistency and accuracy in the testing of drug products.