fluoxetine 40 mg
1 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 Fluoxetine Hydrochloride and Olanzapine Capsules. Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) ( 1 ) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) ( 1 ) Acute and maintenance treatment of Bulimia Nervosa in adult patients ( 1 ) Acute treatment of Panic Disorder, with or without agoraphobia ( 1 ) Fluoxetine and olanzapine in combination for : Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 ) Treatment Resistant Depression ( 1 )
par pharmaceutical, inc.
CAPSULE BLUE 872 par
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine capsules, USP is manufactured by Par Pharmaceutical. The 40mg 1 capsule is a light blue opaque cap and opaque white body, imprinted with “872” on the cap and “par” on the body. NDC 49884-872-11 - Bottle of 30 NDC 49884-872-01 - Bottle of 100 NDC 49884-872-05 - Bottle of 500 1 Fluoxetine base equivalent. 16.2 Storage and Handling Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F). Protect from light.
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