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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,... -
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... -
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... -
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... -
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... -
Dissolution Methods Database recent views
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution... -
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... -
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... -
Approved Animal Drug Products (Green Book) recent views
On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions, the Act... -
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... -
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... -
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... -
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,... -
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... -
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... -
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. -
MAUDE (Manufacturer and User Facility Device Experience) recent views
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991,... -
Premarket Notifications (510(k)s) recent views
Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or... -
FDA Acronyms and Abbreviations recent views
The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities
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