Drugs@FDA is FDA's official database for information on approved human drug products.
Official resource
What it provides
The database can be searched by drug name, active ingredient, application number and related identifiers. Product records can include approval history, labelling, letters, reviews and other regulatory documents depending on the application.
Practical use
For pharmacovigilance work, Drugs@FDA is a primary source for confirming the U.S. regulatory history of a product and retrieving FDA-approved prescribing information. It is particularly useful when determining when a safety-related labelling change entered the approved U.S. label or when comparing current and historical approval actions.
Use the approved labelling and regulatory record rather than assuming that a third-party drug-information site reflects the latest FDA position.