Application Nr Approved Date Route Status External Links
ANDA202674 2016-03-08 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Quetiapine Tablets, Usp Are An Atypical Antipsychotic Indicated For The Treatment Of: Schizophrenia ( 1.1) Bipolar I Disorder Manic Episodes ( 1.2) Bipolar Disorder, Depressive Episodes ( 1.2) 1.1 Schizophrenia Quetiapine Tablets, Usp Are Indicated For The Treatment Of Schizophrenia. The Efficacy Of Quetiapine Tablets, Usp In Schizophrenia Was Established In Three 6-Week Trials In Adults And One 6-Week Trial In Adolescents (13 To 17 Years). The Effectiveness Of Quetiapine Tablets, Usp For The Maintenance Treatment Of Schizophrenia Has Not Been Systematically Evaluated In Controlled Clinical Trials [see Clinical Studies (14.1)] . 1.2 Bipolar Disorder Quetiapine Tablets, Usp Are Indicated For The Acute Treatment Of Manic Episodes Associated With Bipolar I Disorder, Both As Monotherapy And As An Adjunct To Lithium Or Divalproex. Efficacy Was Established In Two 12-Week Monotherapy Trials In Adults, In One 3-Week Adjunctive Trial In Adults, And In One 3-Week Monotherapy Trial In Pediatric Patients (10 To 17 Years) [see Clinical Studies (14.2)] . Quetiapine Tablets, Usp Are Indicated As Monotherapy For The Acute Treatment Of Depressive Episodes Associated With Bipolar Disorder. Efficacy Was Established In Two 8-Week Monotherapy Trials In Adult Patients With Bipolar I And Bipolar Ii Disorder [see Clinical Studies (14.2)] . Quetiapine Tablets, Usp Are Indicated For The Maintenance Treatment Of Bipolar I Disorder, As An Adjunct To Lithium Or Divalproex. Efficacy Was Established In Two Maintenance Trials In Adults. The Effectiveness Of Quetiapine Tablets, Usp As Monotherapy For The Maintenance Treatment Of Bipolar Disorder Has Not Been Systematically Evaluated In Controlled Clinical Trials [see Clinical Studies (14.2)] . 1.3 Special Considerations In Treating Pediatric Schizophrenia And Bipolar I Disorder Pediatric Schizophrenia And Bipolar I Disorder Are Serious Mental Disorders, However, Diagnosis Can Be Challenging. For Pediatric Schizophrenia, Symptom Profiles Can Be Variable, And For Bipolar I Disorder, Patients May Have Variable Patterns Of Periodicity Of Manic Or Mixed Symptoms. It Is Recommended That Medication Therapy For Pediatric Schizophrenia And Bipolar I Disorder Be Initiated Only After A Thorough Diagnostic Evaluation Has Been Performed And Careful Consideration Given To The Risks Associated With Medication Treatment. Medication Treatment For Both Pediatric Schizophrenia And Bipolar I Disorder Is Indicated As Part Of A Total Treatment Program That Often Includes Psychological, Educational And Social Interventions.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Starch, Corn STARCH, CORN Unresolved
3. Calcium Phosphate, Dibasic, Dihydrate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE Molecular
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Hypromelloses HYPROMELLOSES Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Quetiapine Fumarate QUETIAPINE FUMARATE ZINC19632628

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