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719 datasets found
  • Federal

    Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

    U.S. Department of Health & Human Services —

    A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved...
  • Federal

    Fluoxetine

    U.S. Department of Health & Human Services —

    Fluoxetine Hydrochloride is a prescription antidepressant medication available as 60 mg oral tablets. Manufactured by Aurobindo Pharma Limited, it is a generic form...
  • Federal

    Radiation-emitting Electronic Product Codes

    U.S. Department of Health & Human Services —

    This database contains product names and associated information developed by the Center for all products, both medical and non-medical, which emit radiation. It...
  • Federal

    Montelukast sodium

    U.S. Department of Health & Human Services —

    Montelukast Sodium is a prescription medication available as oral granules, each packet containing 4 mg of the active ingredient. Manufactured by Aurobindo Pharma...
  • Federal

    Tisotumab vedotin

    U.S. Department of Health & Human Services —

    Tivdak (tisotumab vedotin) is a prescription biologic drug manufactured by Seagen Inc., approved under BLA 761208. It's an injectable powder for intravenous solution,...
  • Federal

    Ethosuximide

    U.S. Department of Health & Human Services —

    Ethosuximide is a prescription medication used to treat absence seizures (petit mal epilepsy). This generic oral capsule, containing 250 mg of ethosuximide per dose,...
  • Federal

    Norethindrone

    U.S. Department of Health & Human Services —

    Incassia is a prescription oral tablet containing 0.35 mg of norethindrone, a progestin hormone. It's used for birth control to prevent pregnancy by regulating...
  • Federal

    Dantrolene

    U.S. Department of Health & Human Services —

    Dantrolene Sodium is a prescription injectable medication manufactured by Hikma Pharmaceuticals USA Inc., used as a skeletal muscle relaxant. It comes as a 20 mg...
  • Federal

    Methadone hydrochloride

    U.S. Department of Health & Human Services —

    Methadone Hydrochloride is a prescription opioid medication used to manage severe pain or treat opioid dependence. Available as oral tablets in 5mg and 10mg...
  • Federal

    Benzonatate

    U.S. Department of Health & Human Services —

    Benzonatate is a prescription drug that helps suppress coughing by reducing activity in the airways. Available as 100mg and 200mg oral capsules, it's a non-narcotic...
  • Federal

    Lorazepam

    U.S. Department of Health & Human Services —

    Lorazepam is a prescription benzodiazepine medication available as oral tablets in strengths of 0.5 mg, 1 mg, and 2 mg. Manufactured by Leading Pharma, LLC, it is a...
  • Federal

    Haloperidol

    U.S. Department of Health & Human Services —

    Haloperidol is a generic antipsychotic medication used to manage symptoms of schizophrenia, bipolar disorder, and other mental health conditions. It comes as oral...
  • Federal

    Doxazosin mesylate

    U.S. Department of Health & Human Services —

    Doxazosin Mesylate is a prescription medication available as oral tablets in strengths of 1mg, 2mg, 4mg, and 8mg. It belongs to the class of alpha-adrenergic blockers...
  • Federal

    Ripretinib

    U.S. Department of Health & Human Services —

    Qinlock (ripretinib) is an oral prescription tablet that acts as a kinase inhibitor, targeting enzymes like KIT and PDGFR alpha to help manage certain cancers....
  • Federal

    Sevelamer carbonate

    U.S. Department of Health & Human Services —

    Sevelamer Carbonate is a prescription medication available as 800 mg oral tablets. It acts as a phosphate binder to help lower high phosphate levels in the blood,...
  • Federal

    Mesna

    U.S. Department of Health & Human Services —

    Mesna (brand name Mesnex) is a prescription medication used to protect the bladder from damage caused by chemotherapy drugs like ifosfamide or cyclophosphamide. It is...
  • Federal

    Adapalene

    U.S. Department of Health & Human Services —

    Adapalene is an over-the-counter topical gel used to treat mild to moderate acne. It contains 0.1% adapalene, a retinoid that helps unclog pores, reduce inflammation,...
  • Federal

    Irbesartan

    U.S. Department of Health & Human Services —

    Irbesartan is a generic prescription medication used to treat high blood pressure and certain kidney problems in people with type 2 diabetes. It works by relaxing...
  • Federal

    Bosentan

    U.S. Department of Health & Human Services —

    Bosentan is a prescription medication used to treat pulmonary arterial hypertension (PAH), a condition where blood pressure in the lungs is too high. It works by...
  • Federal

    Caspofungin acetate

    U.S. Department of Health & Human Services —

    Caspofungin Acetate is an antifungal medication used to treat serious fungal infections. It belongs to the echinocandin class and is administered intravenously as a...
719 datasets found

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