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- Orange Book: Approved Drug Products with Therapeutic Equivalence . . .
To download the Orange Book product information into a spreadsheet that can be searched by additional fields see the download Instructions Find Patent Information
- Orange Book Data File Download Instructions - accessdata. fda. gov
Orange Book Data File Download Instructions A step-by-step guide to download the latest Orange Book monthly data to Microsoft Excel on Microsoft Windows* *Microsoft Excel for Microsoft 365 MSO (Version 2302) is displayed above as an example for demonstration purposes only
- Search Orphan Drug Designations and Approvals
This page searches the Orphan Drug Product designation database Searches may be run by entering the product name, orphan designation, and dates Results can be displayed as a condensed list, detailed list, or an Excel spreadsheet Click for detailed instructions
- MDR Database Search - Food and Drug Administration
MDR Database SearchFDA Home Medical Device Databases
- Establishment Registration Device Listing - Food and Drug Administration
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
- Mammography Facilities - Food and Drug Administration
The Mammography Facility Database is updated periodically based on information received from the three FDA-approved accreditation bodies: the American College of Radiology (ACR), and the states of Arkansas and Texas
- Product Classification - Food and Drug Administration
This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information
- 510 (K) Premarket Notification - Food and Drug Administration
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 (section 513 (i) (1) (A) FD C Act) that is not subject to premarket approval
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