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Federal
Drugs@FDA Database
U.S. Department of Health & Human Services —
Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of... -
Federal
Orange Book
U.S. Department of Health & Human Services —
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... -
Federal
National Drug Code Directory
U.S. Department of Health & Human Services —
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,... -
Federal
CLIA Currently Waived Analytes
U.S. Department of Health & Human Services —
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... -
Federal
Warning Letters
U.S. Department of Health & Human Services —
An index of FDA warning letters issued to companies operating in the United States. -
Federal
Drug Establishments Current Registration Site
U.S. Department of Health & Human Services —
The Drug Establishments Current Registration Site (DECRS) is a database of current information submitted by drug firms to register establishments (facilities) which... -
Federal
FDA Recognized Consensus Standards
U.S. Department of Health & Human Services —
This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information... -
Federal
Inactive ingredient Search for Approved Drug Products
U.S. Department of Health & Human Services —
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... -
Federal
Establishment Registration & Device Listing
U.S. Department of Health & Human Services —
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices... -
Federal
Clinical Investigator Inspector List (CLIIL)
U.S. Department of Health & Human Services —
The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who... -
Federal
Total Product Life Cycle (TPLC)
U.S. Department of Health & Human Services —
The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases... -
Federal
Enforcement Reports
U.S. Department of Health & Human Services —
Whereas not all recalls are announced in the media or on our Recalls press release page, all recalls montiored by FDA are included in FDA's weekly Enforcement Report... -
Federal
Product Classification
U.S. Department of Health & Human Services —
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... -
Federal
Dissolution Methods Database
U.S. Department of Health & Human Services —
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... -
Federal
Recalls of Food and Dietary Supplements
U.S. Department of Health & Human Services —
Food producers recall their products from the marketplace when the products are mislabeled or when the food may present a health hazard to consumers because the food... -
Federal
Adverse Event Reporting System (AERS)
U.S. Department of Health & Human Services —
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all... -
Federal
Drugs to be Discontinued
U.S. Department of Health & Human Services —
Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and... -
Federal
Approved Animal Drug Products (Green Book)
U.S. Department of Health & Human Services —
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... -
Federal
FDA Online Label Repository
U.S. Department of Health & Human Services —
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... -
Federal
Inspection Database
U.S. Department of Health & Human Services —
FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not...