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A patient package insert contains information for patients' understanding of how to safely use a drug product.
- 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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FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria:
- they contain the same active ingredient(s)
- they are of the same dosage form and route of administration
- they are identical in strength or concentration
Pharmaceutically equivalent drug products may differ in characteristics such as
- shape
- release mechanism
- labeling (to some extent)
- scoring
- excipients (including colors, flavors, preservatives)
- 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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An adaptive physiological state that occurs with regular drug use and results in a withdrawal syndrome when drug use is stopped; often occurs with tolerance. Physical dependence can happen with chronic—even appropriate—use of many medications, and by itself does not constitute addiction.
- Browse Related Terms: addiction, central nervous system, Comorbidity, Dopamine, Norepinephrine, Physical Dependence, Stimulants, Tolerance, Withdrawal
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All > Healthcare > Medicine > Drug
The abuse of two or more drugs at the same time, such as CNS depressants and alcohol.
- Browse Related Terms: barbiturate, Benzodiazepine, CNS Depressants, Narcolepsy, Polydrug Abuse, Prescription Drug Abuse, Psychotherapeutics, Respiratory Depression, Sedatives, Tranquilizers
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The use of a medication without a prescription; in a way other than as prescribed; or for the experience or feeling elicited. This term is used interchangeably with "nonmedical" use, a term employed by many of the national surveys.
- Browse Related Terms: barbiturate, Benzodiazepine, CNS Depressants, Narcolepsy, Polydrug Abuse, Prescription Drug Abuse, Psychotherapeutics, Respiratory Depression, Sedatives, Tranquilizers
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A prescription drug product requires a doctor's authorization to purchase.
- 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 product number is assigned to each drug product associated with an NDA (New Drug Application). If a drug product is available in multiple strengths, there are multiple product numbers.
- 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
All > Healthcare > Medicine > Drug
Drugs that have an effect on the function of the brain and that often are used to treat psychiatric/neurologic disorders; includes opioids, CNS depressants, and stimulants.
- Browse Related Terms: barbiturate, Benzodiazepine, CNS Depressants, Narcolepsy, Polydrug Abuse, Prescription Drug Abuse, Psychotherapeutics, Respiratory Depression, Sedatives, Tranquilizers