fluoxetine

FDA Drug Profile — FLUOXETINE

Drug Details

Generic Name
fluoxetine
Brand Names
FLUOXETINE
Application Number
ANDA212684
Sponsor
Strides Pharma Science Limited
NDC Codes
3
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
FLUOXETINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Olanzapine and fluoxetine capsules are indicated for the treatment of: Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1) ]. Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2) ]. Olanzapine and fluoxetine capsules combine olanzapine, an atypical antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor, indicated for treatment of: Acute Depressive Episodes Associated with Bipolar I Disorder (1) Treatment Resistant Depression (1)