Application Nr Approved Date Route Status External Links
ANDA078619 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluoxetine Capsules Are Indicated For The Treatment Of: Acute And Maintenance Treatment Of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute And Maintenance Treatment Of Obsessions And Compulsions In Patients With Obsessive Compulsive Disorder (ocd) [see Clinical Studies (14.2) ] . Acute And Maintenance Treatment Of Binge-Eating And Vomiting Behaviors In Patients With Moderate To Severe Bulimia Nervosa [see Clinical Studies (14.3) ] . Acute Treatment Of Panic Disorder, With Or Without Agoraphobia [see Clinical Studies (14.4) ] . Fluoxetine Capsules And Olanzapine In Combination Are Indicated For The Treatment Of: Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder. Fluoxetine Capsules Monotherapy Is Not Indicated For The Treatment Of Depressive Episodes Associated With Bipolar I Disorder. When Using Fluoxetine Capsules And Olanzapine In Combination, Also Refer To The Clinical Studies Section Of The Package Insert For Symbyax ® . Fluoxetine Capsules Are A Selective Serotonin Reuptake Inhibitor Indicated For: Acute And Maintenance Treatment Of Major Depressive Disorder (mdd) ( 1 ) Acute And Maintenance Treatment Of Obsessive Compulsive Disorder (ocd) ( 1 ) Acute And Maintenance Treatment Of Bulimia Nervosa ( 1 ) Acute Treatment Of Panic Disorder, With Or Without Agoraphobia ( 1 ) Fluoxetine Capsules And Olanzapine In Combination For Treatment Of: Acute Depressive Episodes Associated With Bipolar I Disorder ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluoxetine Hydrochloride FLUOXETINE HYDROCHLORIDE ZINC1530637

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