Application Nr Approved Date Route Status External Links
ANDA090533 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Zenzedi ® (Dextroamphetamine Sulfate Tablets, Usp) Is Indicated For: 1. Narcolepsy. 2. Attention Deficit Disorder With Hyperactivity: As An Integral Part Of A Total Treatment Program Which Typically Includes Other Remedial Measures (Psychological, Educational, Social) For A Stabilizing Effect In Pediatric Patients (Ages 3 To 16 Years) With A Behavioral Syndrome Characterized By The Following Group Of Developmentally Inappropriate Symptoms: Moderate To Severe Distractibility, Short Attention Span, Hyperactivity, Emotional Lability, And Impulsivity. The Diagnosis Of This Syndrome Should Not Be Made With Finality When These Symptoms Are Only Of Comparatively Recent Origin. Nonlocalizing (Soft) Neurological Signs, Learning Disability, And Abnormal Eeg May Or May Not Be Present, And A Diagnosis Of Central Nervous System Dysfunction May Or May Not Be Warranted.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dextroamphetamine Sulfate DEXTROAMPHETAMINE SULFATE ZINC6021033

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