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olanzapine and fuoxetine

FDA Drug Profile — Olanzapine and Fluoxetine

Drug Details

Generic Name
olanzapine and fuoxetine
Brand Names
Olanzapine and Fluoxetine
Application Number
ANDA077742
Sponsor
Endo USA, Inc.
NDC Codes
10
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
FLUOXETINE HYDROCHLORIDE, 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 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 )