Application Nr Approved Date Route Status External Links
ANDA070278 2009-07-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Haloperidol Tablets Are Indicated For Use In The Management Of Manifestations Of Psychotic Disorders. Haloperidol Tablets Are Indicated For The Control Of Tics And Vocal Utterances Of Tourette’s Disorder In Children And Adults. Haloperidol Tablets Are Effective For The Treatment Of Severe Behavior Problems In Children Of Combative, Explosive Hyperexcitability (which Cannot Be Accounted For By Immediate Provocation). Haloperidol Tablets Are Also Effective In The Short-Term Treatment Of Hyperactive Children Who Show Excessive Motor Activity With Accompanying Conduct Disorders Consisting Of Some Or All Of The Following Symptoms: Impulsivity, Difficulty Sustaining Attention, Aggressivity, Mood Lability, And Poor Frustration Tolerance. Haloperidol Tablets Should Be Reserved For These Two Groups Of Children Only After Failure To Respond To Psychotherapy Or Medications Other Than Antipsychotics.

All Formulated Excipients (1 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Haloperidol HALOPERIDOL ZINC537822

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