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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
MAUDE (Manufacturer and User Facility Device Experience)
U.S. Department of Health & Human Services —
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since... -
Federal
Premarket Approvals (PMA)
U.S. Department of Health & Human Services —
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... -
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
Current and Resolved Drug Shortages and Discontinuations Reported to FDA
U.S. Department of Health & Human Services —
Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products. -
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
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
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
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
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
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
NHRIC (National Health Related Items Code)
U.S. Department of Health & Human Services —
The National Health Related Items Code (NHRIC) is a system for identification and numbering of marketed device packages that is compatible with other numbering... -
Federal
Testosterone cypionate
U.S. Department of Health & Human Services —
Testosterone Cypionate is a prescription injectable solution used to supplement testosterone levels in men with low hormone production. It is administered... -
Federal
CFSAN Web Modules
U.S. Department of Health & Human Services —
This system shares public data that can be downloaded. -
Federal
Liothyronine sodium
U.S. Department of Health & Human Services —
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,... -
Federal
Metronidazole oral
U.S. Department of Health & Human Services —
LIKMEZ is a prescription oral suspension containing metronidazole, an antibiotic that treats infections caused by certain bacteria and parasites. Each 5 mL provides... -
Federal
MedSun Reports
U.S. Department of Health & Human Services —
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002. The primary goal for MedSun is to work collaboratively with the... -
Federal
IVD Home Use Lab Tests (Over The Counter) Tests
U.S. Department of Health & Human Services —
Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA -
Federal
Dicyclomine hydrochloride
U.S. Department of Health & Human Services —
Dicyclomine Hydrochloride is a prescription anticholinergic medication used to treat symptoms of irritable bowel syndrome, such as abdominal pain and cramping. It... -
Federal
Dorzolamide hydrochloride and timolol maleate preservative free
U.S. Department of Health & Human Services —
Dorzolamide Hydrochloride and Timolol Maleate is a preservative-free ophthalmic solution (eye drops) used to lower intraocular pressure in patients with glaucoma or...