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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... -
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,... -
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... -
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... -
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... -
Establishment Registration & Device Listing
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for... -
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... -
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... -
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... -
Testosterone cypionate
Testosterone Cypionate is a prescription injectable solution used to supplement testosterone levels in men with low hormone production. It is administered intramuscularly at a... -
Empagliflozin, linagliptin, metformin hydrochloride
Trijardy XR is a prescription medication combining empagliflozin, linagliptin, and metformin to help manage type 2 diabetes by lowering blood sugar levels. It's taken orally as... -
MedSun Reports
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 clinical... -
Cetirizine hydrochloride
Cetirizine Hydrochloride is a prescription antihistamine used to relieve allergy symptoms such as runny nose, itchy eyes, sneezing, and hives. It comes as an oral solution with... -
Dicyclomine hydrochloride
Dicyclomine Hydrochloride is a prescription anticholinergic medication used to treat symptoms of irritable bowel syndrome, such as abdominal pain and cramping. It comes as 10 mg... -
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... -
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,...
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