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An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
- Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification
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This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.
- Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification
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An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.
- Browse Related Terms: Active Ingredient, agonist, antagonist, Biological Product, Buprenorphine, Detoxification, Drug, methadone, Opioid, Therapeutic Biological Product
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A chronic, relapsing disease characterized by compulsive drug seeking and use, despite serious adverse consequences, and by long-lasting changes in the brain.
- Browse Related Terms: addiction, central nervous system, Comorbidity, Dopamine, Norepinephrine, Physical Dependence, Stimulants, Tolerance, Withdrawal
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A chemical entity that binds to a receptor and activates it, mimicking the action of the natural (or abused) substance that binds there.
- Browse Related Terms: Active Ingredient, agonist, antagonist, Biological Product, Buprenorphine, Detoxification, Drug, methadone, Opioid, Therapeutic Biological Product
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A chemical entity that binds to a receptor and blocks its activation. Antagonists prevent the natural (or abused) substance from activating its receptor.
- Browse Related Terms: Active Ingredient, agonist, antagonist, Biological Product, Buprenorphine, Detoxification, Drug, methadone, Opioid, Therapeutic Biological Product
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- See New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA).
- Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification
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All > Healthcare > Medicine > Drug
- See FDA Application Number
- Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification
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The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.
- Browse Related Terms: Approval History, Discontinued Drug Product, FDA Action Date, label, Marketing Status, Reference Listed Drug (RLD), Route, Supplement, Supplement Number, Supplement Type, Tentative Approval
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An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.
- Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification
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A type of CNS depressant prescribed to promote sleep (usually in surgical procedures) or as an anticonvulsant.
- Browse Related Terms: barbiturate, Benzodiazepine, CNS Depressants, Narcolepsy, Polydrug Abuse, Prescription Drug Abuse, Psychotherapeutics, Respiratory Depression, Sedatives, Tranquilizers
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A type of CNS depressant prescribed to relieve anxiety and sleep problems. Valium and Xanax are among the most widely prescribed medications.
- Browse Related Terms: barbiturate, Benzodiazepine, CNS Depressants, Narcolepsy, Polydrug Abuse, Prescription Drug Abuse, Psychotherapeutics, Respiratory Depression, Sedatives, Tranquilizers
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Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.
- Browse Related Terms: Abbreviated New Drug Application (ANDA), Abbreviated New Drug Application (ANDA) Number, application, Application Number, Approval Letter, Biologic License Application (BLA), Company, FDA Application Number, New Drug Application (NDA), New Drug Application (NDA) Number, Product Number, Review, Review Classification
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Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
In general, the term "drugs" includes therapeutic biological products.
- Browse Related Terms: Active Ingredient, agonist, antagonist, Biological Product, Buprenorphine, Detoxification, Drug, methadone, Opioid, Therapeutic Biological Product
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A brand name drug is a drug marketed under a proprietary, trademark-protected name.
- Browse Related Terms: Brand Name Drug, Chemical Type, Dosage Form, Drug Product, Generic Drug, Medication Guide, New Molecular Entity (NME), Over-the-Counter Drugs (OTC), Patient Package Insert (PPI), Pharmaceutical Equivalents, Prescription Drug Product, Strength, Therapeutic Equivalence (TE), Therapeutic Equivalence (TE) Codes
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A mixed opiate agonist/antagonist medication approved by the FDA in October 2002 for the treatment of opioid addiction (e.g., heroin).
- Browse Related Terms: Active Ingredient, agonist, antagonist, Biological Product, Buprenorphine, Detoxification, Drug, methadone, Opioid, Therapeutic Biological Product
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The brain and spinal cord.
- Browse Related Terms: addiction, central nervous system, Comorbidity, Dopamine, Norepinephrine, Physical Dependence, Stimulants, Tolerance, Withdrawal
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The Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation. For example, Chemical Type 1 is assigned to an active ingredient that has never before been marketed in the United States in any form.
- Browse Related Terms: Brand Name Drug, Chemical Type, Dosage Form, Drug Product, Generic Drug, Medication Guide, New Molecular Entity (NME), Over-the-Counter Drugs (OTC), Patient Package Insert (PPI), Pharmaceutical Equivalents, Prescription Drug Product, Strength, Therapeutic Equivalence (TE), Therapeutic Equivalence (TE) Codes
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A class of drugs that slow CNS function (also called sedatives and tranquilizers), some of which are used to treat anxiety and sleep disorders; includes barbiturates and benzodiazepines.
- Browse Related Terms: barbiturate, Benzodiazepine, CNS Depressants, Narcolepsy, Polydrug Abuse, Prescription Drug Abuse, Psychotherapeutics, Respiratory Depression, Sedatives, Tranquilizers
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The occurrence of two disorders or illnesses in the same person, also referred to as co-occurring conditions or dual diagnosis. Patients with comorbid illnesses may experience a more severe illness course and require treatment for each or all conditions.
- Browse Related Terms: addiction, central nervous system, Comorbidity, Dopamine, Norepinephrine, Physical Dependence, Stimulants, Tolerance, Withdrawal
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