Application Nr Approved Date Route Status External Links
ANDA076990 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluoxetine Capsules, Usp 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, Usp And Olanzapine In Combination Are Indicated For The Treatment Of: • Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder. Fluoxetine Capsules, Usp Monotherapy Is Not Indicated For The Treatment Of Depressive Episodes Associated With Bipolar I Disorder. When Using Fluoxetine Capsules, Usp And Olanzapine In Combination, Also Refer To The Clinical Studies Section Of The Package Insert For Olanzapine And Fluoxetine Hydrochloride Capsules. Fluoxetine Capsules, Usp Is 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, Usp 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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