Drug Approvals and Databases | FDA
Sep 24, 2025 · Product-Specific Guidances for Generic Drug Development Database More Information Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and …
Establishment Registration & Device Listing - Food and Drug Administration
6 days ago · Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.
FDA Industry Systems
Oct 31, 2023 · FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. FIS has …
FDA Data Dashboard
Feb 24, 2021 · The Data Dashboard is designed to support the understanding, accountability, and analysis of public FDA data through easy to use, visually accessible, customizable, and …
Drugs@FDA Data Files
Feb 17, 2026 · Below you will find a compressed data file of the Drugs@FDA database. It does not include the scripts (programming) we use to produce the online version of Drugs@FDA.
FDA Dashboards - Home
The Data Dashboard provides public FDA data in easy to use, visually accessible and understandable graphics.
Drugs@FDA - Food and Drug Administration
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...
Drugs@FDA Database - Catalog
Jul 17, 2025 · 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 …
www.accessdata.fda.gov
Access the FDA's Center for Drug Evaluation and Research resources, including drug approvals, databases, and regulatory information.
510 (k) Premarket Notification - Food and Drug Administration
6 days ago · A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device …