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Clinical research / Design of experiments / Organochlorides / Antiemetics / GlaxoSmithKline / Ondansetron / Schizophrenia / Clinical trial / Child and adolescent psychiatry / Chemistry / Psychiatry / Organic chemistry


N022117 Asenapine Amend 2
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City

Washington / DC / /

Company

NDA 022117 Organon USA Inc / /

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Event

FDA Phase / /

Facility

Columbia University / /

IndustryTerm

clinical protocol / clinical protocols / /

MedicalCondition

adult and adolescent schizophrenia / treatment-resistant childhood-onset schizophrenia / pediatric bipolar disorder / childhood onset schizophrenia / schizophrenia / disease / I Disorder / personality disorder / adult onset schizophrenia / chronic and debilitating illness / posttraumatic stress disorder / Mania / Pediatric Mania / adult and pediatric bipolar disorder / accurately diagnosing schizophrenia / schizophrenic psychoses / same disease / childhood schizophrenia / psychotic disorders / dyskinesias / mood disorder / disorder / Pediatric Schizophrenia Schizophrenia / MS / developmental language disorders / adult schizophrenia / disorders / bipolar disorder / Mental Disorders / pervasive developmental disorders / adolescent schizophrenia / /

MedicalTreatment

clinical protocols / clinical protocol / /

Organization

Division of Psychiatry Products / Bibliography American Academy of Child and Adolescent Psychiatry / American Psychiatric Association / Columbia University / Food and Drug Administration / Data Safety Monitoring Board / DEPARTMENT OF HEALTH / American Academy of Child and Adolescent Psychiatry / /

Person

Silver Spring / Jill Kompa / Kelly Posner / /

Position

investigator / author / e.g. child psychiatrist / PEDIATRIC SCHIZOPHRENIA General / PEDIATRIC BIPOLAR DISORDER General / /

Product

022117Page 9 Pediatric / Sublingual Tablets / Human Drug / sublingual / K-6-1 / /

ProvinceOrState

New Jersey / Maryland / /

PublishedMedium

the Past 10 Years Journal / American Journal of Psychiatry / /

Technology

alpha / clinical protocols / clinical protocol / /

URL

www.fda.gov/cder/guidance/index.htm / /

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