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For Consumers

A Catalog of FDA Approved Drug Products

4/28/2003

Available on the FDA web site:
A Catalog of FDA Approved Drug Products
FDA announces Drugs@FDA: A Catalog of FDA Approved Drug Products, a pilot project that provides a single, searchable internet source where you can search for official, up-to-date information about FDA approved brand name and generic drugs(including those for the treatment of HIV/AIDS and related conditions).

Prescription, over-the-counter, and discontinued drugs are included in the database. Links are provided to access approval letters, labels, and scientific reviews. The majority of labels, approval letters, reviews, and other information are available for drug products approved from 1998 to the present.

Drugs@FDA does not include:

Dietary supplements.
Drugs for animals. Drugs withdrawn for reasons of safety or effectiveness.
Over-the-counter products that are approved for marketing though a process other than submitting a New Drug Application.
Prescription drugs sold in countries other than the United States.
Prescription drugs sold (illegally) in the United States without FDA approval.
Drugs that are under review at FDA for which no action regarding approval has occurred.
Biological products including bacterial and viral vaccines; human blood products; certain products produced by biotechnology, such as interferons and erythropoietins; and gene therapy. You can access the site at
http://www.accessdata.fda.gov/scripts/cder/drugcat/
[Note, 8-1-2005: The URL for Drugs@FDA is now http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Search results for all drug products include:

drug name (brand name or generic name)
active ingredient
form and route of administration
strength
marketing status (prescription, over-the-counter, or discontinued)
company that sponsored an application for approval
FDA action date
Product numbers
Supplement type (type of regulatory action)

This is a pilot project of FDA. Your comments, which can be submitted at the website, are encouraged.

Richard Klein
Office of Special Health Issues
Food and Drug Administration
 

Page Last Updated: 08/01/2014
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