Application Nr Approved Date Route Status External Links
ANDA071173 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Haloperidol Tablets, Usp Are Indicated For Use In The Management Of Manifestations Of Psychotic Disorders. Haloperidol Tablets, Usp Are Indicated For The Control Of Tics And Vocal Utterances Of Tourette’s Disorder In Children And Adults. Haloperidol Tablets, Usp 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, Usp 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, Usp Should Be Reserved For These Two Groups Of Children Only After Failure To Respond To Psychotherapy Or Medications Other Than Antipsychotics.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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