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A disorder characterized by uncontrollable episodes of deep sleep.
- Browse Related Terms: barbiturate, Benzodiazepine, CNS Depressants, Narcolepsy, Polydrug Abuse, Prescription Drug Abuse, Psychotherapeutics, Respiratory Depression, Sedatives, Tranquilizers
All > Healthcare > Medicine > Drug
When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA 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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This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration. In [email protected], you can find the NDA number under the column named "FDA Application."
- 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 New Molecular Entity is 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 neurotransmitter present in the brain and the peripheral (sympathetic) nervous system; and a hormone released by the adrenal glands. Norepinephrine is involved in attention, responses to stress, and it regulates smooth muscle contraction, heart rate, and blood pressure.
- Browse Related Terms: addiction, central nervous system, Comorbidity, Dopamine, Norepinephrine, Physical Dependence, Stimulants, Tolerance, Withdrawal
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