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  • 665 datasets found

    Bureaus: 009:10 Formats: HTML

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    • Fezolinetant

      VEOZAH (fezolinetant) is a prescription tablet by Astellas Pharma US, Inc., approved in May 2023. It works as a neurokinin 3 receptor antagonist to treat moderate to severe hot...
    • Food Code Reference System

      The Food Code Reference System (FCRS) is a searchable database that provides access to FDA�s interpretative positions and responses to questions related to the FDA Food Code....
    • Butalbital, acetaminophen and caffeine

      Butalbital, Acetaminophen, and Caffeine is a prescription tablet used to relieve tension headaches. It combines butalbital (a sedative), acetaminophen (pain reliever), and...
    • Cefazolin

      Cefazolin is a generic antibiotic medication, belonging to the cephalosporin class, used to treat bacterial infections. It comes as a powder for injection, administered...
    • Fexofenadine hcl

      Fexofenadine Hydrochloride is an over-the-counter antihistamine tablet that helps relieve symptoms of indoor and outdoor allergies, such as runny nose, itchy eyes, and hives....
    • Chlordiazepoxide hydrochloride and clidinium bromide

      Chlordiazepoxide Hydrochloride and Clidinium Bromide is a prescription medication combining a benzodiazepine and an anticholinergic to help manage symptoms of irritable bowel...
    • IVD Home Use Lab Tests (Over The Counter) Tests

      Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA
    • Fluphenazine hydrochloride

      Fluphenazine Hydrochloride is a prescription injectable medication used to treat schizophrenia and other mental health conditions. It belongs to the phenothiazine class of drugs...
    • Losartan potassium

      Losartan Potassium is a prescription medication that helps lower high blood pressure and treat heart failure by blocking substances that tighten blood vessels. Available as oral...
    • Chlorhexidine gluconate 4%

      Chlorhexidine Gluconate is an antiseptic skin cleanser and surgical scrub available over-the-counter in a 4% topical solution. It's used to reduce bacteria on the skin before...
    • 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...
    • Lidocaine and prilocaine

      Lidocaine and Prilocaine is a prescription topical cream containing 2.5% lidocaine and 2.5% prilocaine, used as a local anesthetic to numb the skin before minor procedures like...
    • Ezetimibe

      Ezetimibe is a generic prescription medication that helps lower cholesterol levels by reducing the absorption of dietary cholesterol in the intestines. It comes as 10 mg oral...
    • Recalls of Medical Devices

      This database contains a list of classified medical device recalls since November 1, 2002
    • Gemfibrozil

      Gemfibrozil is a prescription medication that helps lower high levels of cholesterol and triglycerides in the blood, reducing the risk of heart disease. It comes as 600mg oral...
    • Dutasteride

      Dutasteride is a prescription oral capsule (0.5 mg) that acts as a 5-alpha reductase inhibitor, commonly used to treat benign prostatic hyperplasia (enlarged prostate) and male...
    • Atenolol

      Atenolol is a prescription medication that belongs to a class of drugs called beta-blockers. It is used to treat high blood pressure, chest pain (angina), and certain heart...
    • Perampanel

      Fycompa (perampanel) is a prescription medication that acts as a noncompetitive AMPA glutamate receptor antagonist to help control seizures in epilepsy patients. Available as...
    • Milnacipran hcl

      Milnacipran HCl is a generic prescription medication, available as oral tablets in strengths of 12.5 mg, 25 mg, 50 mg, and 100 mg. It works as a serotonin and norepinephrine...
    • Everolimus

      Everolimus is an oral prescription medication that acts as an immunosuppressant and mTOR inhibitor, used to prevent organ rejection in transplant patients and treat certain...