olanzapine

FDA Drug Profile — Olanzapine

Drug Details

Generic Name
olanzapine
Brand Names
Olanzapine
Application Number
ANDA078109
Sponsor
Strides Pharma Science Limited
NDC Codes
4
Dosage Forms
TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients
OLANZAPINE

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 combines 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 )