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Drugs that suppress anxiety and promote sleep; the NSDUH classification includes benzodiazepines, barbiturates, and other types of CNS depressants.
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A class of drugs that enhances the activity of monamines (such as dopamine) in the brain, increasing arousal, heart rate, blood pressure, and respiration, and decreasing appetite; includes some medications used to treat attention-deficit hyperactivity disorder (e.g., methylphenidate and amphetamines), as well as cocaine and methamphetamine.
- Browse Related Terms: addiction, central nervous system, Comorbidity, Dopamine, Norepinephrine, Physical Dependence, Stimulants, Tolerance, Withdrawal
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The strength of a drug product tells how much of the active ingredient is present in each dosage.
- 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 supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA). CDER must approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met.
- 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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A supplement number is associated with an existing FDA New Drug Application (NDA) number. Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001.
- 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
All > Healthcare > Medicine > Drug
Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). The supplement type refers to the kind of change that was approved by FDA. This includes changes in manufacturing, patient population, and formulation.
- 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