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MAUDE (Manufacturer and User Facility Device Experience)
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,... -
Orange Book
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... -
CLIA Currently Waived Analytes
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... -
Current and Resolved Drug Shortages and Discontinuations Reported to FDA
Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products. -
Enforcement Reports
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 once they... -
Total Product Life Cycle (TPLC)
The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including... -
Establishment Registration & Device Listing
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for... -
FDA Recognized Consensus Standards
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... -
Premarket Approvals (PMA)
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved... -
Approved Animal Drug Products (Green Book)
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)
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... -
Code of Federal Regulations Title 21
This database contains the most recent revision from the Government Printing Office (GPO) of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs. -
Recalls of Food and Dietary Supplements
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 is... -
Dorzolamide hydrochloride and timolol maleate preservative free
Dorzolamide Hydrochloride and Timolol Maleate is a preservative-free ophthalmic solution (eye drops) used to lower intraocular pressure in patients with glaucoma or ocular... -
Dissolution Methods Database
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... -
Metronidazole oral
LIKMEZ is a prescription oral suspension containing metronidazole, an antibiotic that treats infections caused by certain bacteria and parasites. Each 5 mL provides 500 mg of... -
Dexmethylphenidate hydrochloride
Dexmethylphenidate Hydrochloride Extended-Release is a prescription stimulant medication used to treat attention deficit hyperactivity disorder (ADHD). It comes as extended-... -
Bempedoic acid and ezetimibe
Nexlizet is a prescription tablet combining bempedoic acid (180 mg) and ezetimibe (10 mg) to help lower cholesterol levels. It works by reducing cholesterol production in the... -
Liothyronine sodium
Liothyronine Sodium is a generic prescription medication used to treat thyroid hormone deficiency (hypothyroidism). It comes as oral tablets in strengths of 0.005 mg, 0.025 mg,... -
Mammography Facilities
The Mammography Facility Database is updated periodically based on information received from the four FDA-approved accreditation bodies: the American College of Radiology (ACR),...
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