Application Nr Approved Date Route Status External Links
ANDA204772 2016-02-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously Known As Minimal Brain Dysfunction In Children). Other Terms Being Used To Describe The Behavioral Syndrome Below Include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate Hydrochloride Extended-Release Tablets Are Indicated As An Integral Part Of A Total Treatment Program Which Typically Includes Other Remedial Measures (psychological, Educational, Social) For A Stabilizing Effect In Children 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. Special Diagnostic Considerations Specific Etiology Of This Syndrome Is Unknown, And There Is No Single Diagnostic Test. Adequate Diagnosis Requires The Use Not Only Of Medical But Of Special Psychological, Educational, And Social Resources. Characteristics Commonly Reported Include: Chronic History Of Short Attention Span, Distractibility, Emotional Lability, Impulsivity, And Moderate-To-Severe Hyperactivity; Minor Neurological Signs And Abnormal Eeg. Learning May Or May Not Be Impaired. The Diagnosis Must Be Based Upon A Complete History And Evaluation Of The Child And Not Solely On The Presence Of One Or More Of These Characteristics. Drug Treatment Is Not Indicated For All Children With This Syndrome. Stimulants Are Not Intended For Use In The Child Who Exhibits Symptoms Secondary To Environmental Factors And/or Primary Psychiatric Disorders, Including Psychosis. Appropriate Educational Placement Is Essential And Psychosocial Intervention Is Generally Necessary. When Remedial Measures Alone Are Insufficient, The Decision To Prescribe Stimulant Medication Will Depend Upon The Physician's Assessment Of The Chronicity And Severity Of The Child's Symptoms.

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE ZINC2522648

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