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  • 86 datasets found

    Resource Type: dataset Publishers: U.S. Food and Drug Administration

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    • Drugs@FDA Database    recent views

      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...

    • National Drug Code Directory    recent views

      The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared,...

    • FDA Drug Label Data    recent views

      This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number or regulatory...

    • CLIA Currently Waived Analytes    recent views

      This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since January 31, 2000, and by the Centers for Disease Control and...

    • FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files    recent views

      The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed...

    • Total Product Life Cycle (TPLC)    recent views

      The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including...

    • FDA Recognized Consensus Standards    recent views

      This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center...

    • Drug Establishments Current Registration Site    recent views

      The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which manufacture,...

    • Adverse Event Reporting System (AERS)    recent views

      The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug...

    • Orange Book    recent views

      The Approved Drug Products with Therapeutic Equivalence (Orange Book or OB) is a list of drugs approved under Section 505 of the Federal Food, Drug and Cosmetic Act and provides...

    • FDA Pet Food Recalls    recent views

      Contains data for FDA pet food recalls since January 1, 2006.

    • Product Classification    recent views

      This database contains medical device names and associated information developed by the Center. It includes a three letter device product code and a Device Class that refers to...

    • Inactive ingredient Search for Approved Drug Products    recent views

      According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient. Only inactive ingredients in the final dosage forms...

    • All FDA Recalls    recent views

      Contains data for FDA recalls from 2009 through the present.

    • Clinical Investigator Inspector List (CLIIL)    recent views

      The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have...

    • FDA Abbott Infant Formula Recall    recent views

      On September 22, 2010, Abbott issued a voluntary recall of certain Similac powdered infant formula after identifying a common warehouse beetle (both larvae and adults) in the...

    • MDR (Medical Device Reporting)    recent views

      This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the years 1992...

    • NHRIC (National Health Related Items Code)    recent views

      The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering systems such as...

    • Current and Resolved Drug Shortages and Discontinuations Reported to FDA    recent views

      Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products.

    • FDA Online Label Repository    recent views

      The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug...