fluoxetine hcl
fluoxetine hcl is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including FLUOXETINE HCL. Available dosage form: tablet.
Drug Details
- Generic Name
- fluoxetine hcl
- Brand Names
- FLUOXETINE HCL
- Application Number
- ANDA212683
- Sponsor
- Strides Pharma Science Limited
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- FLUOXETINE
Indications and Usage
Fluoxetine is 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 and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.