Application Nr Approved Date Route Status External Links
ANDA201741 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Olanzapine For Injection Is An Atypical Antipsychotic Indicated For The: Treatment Of Acute Agitation Associated With Schizophrenia And Bipolar I Mania. ( 1.4 ) Efficacy Was Established In Three 1-Day Trials In Adults. ( 14.3 ) 1.4 Agitation Associated With Schizophrenia And Bipolar I Mania Olanzapine For Injection Is Indicated For The Treatment Of Acute Agitation Associated With Schizophrenia And Bipolar I Mania. Efficacy Was Demonstrated In 3 Short-Term (24 Hours Of Intramuscular Treatment) Placebo-Controlled Trials In Agitated Adult Inpatients With: Schizophrenia Or Bipolar I Disorder (Manic Or Mixed Episodes) [See Clinical Studies ( 14.3 )]. “psychomotor Agitation” Is Defined In Dsm-Iv As “excessive Motor Activity Associated With A Feeling Of Inner Tension.” Patients Experiencing Agitation Often Manifest Behaviors That Interfere With Their Diagnosis And Care, E.g., Threatening Behaviors, Escalating Or Urgently Distressing Behavior, Or Self-Exhausting Behavior, Leading Clinicians To The Use Of Intramuscular Antipsychotic Medications To Achieve Immediate Control Of The Agitation.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Olanzapine OLANZAPINE ZINC52957434

Comments