olanzapine and fuoxetine
Drug Details
- Generic Name
- olanzapine and fuoxetine
- Brand Names
- Olanzapine and Fluoxetine
- Application Number
- ANDA077742
- Sponsor
- Par Health USA, LLC
- NDC Codes
- 5
- 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 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 )