fluoxetine 40 mg
1 INDICATIONS & USAGE Fluoxetine capsules are 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 capsules 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 patient, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine capsules 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 capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . Fluoxetine capsules are 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 ( 1 ) • Acute treatment of Panic Disorder, with or without agoraphobia ( 1 ) Fluoxetine capsules and olanzapine in combination for treatment of: • Acute Depressive Episodes Associated with Bipolar I Disorder ( 1 ) • Treatment Resistant Depression (1)
Modavar Pharmaceuticals LLC
CAPSULE ORANGE C30
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
FLUOXETINE capsules USP, 10 mg* white to off white powder filled in size "4" hard gelatin capsules with green opaque cap and green opaque body imprinted "C28" Bottles of 30 NDC 72241-007-22 Bottles of 100 NDC 72241-007-05 Bottles of 500 NDC 72241-007-10 Bottles of 1,000 NDC 72241-007-11
FLUOXETINE capsules USP, 20 mg* white to off white powder filled in size "2" hard gelatin capsules with green opaque cap and yellow opaque body imprinted "C29" Bottles of 30 NDC 72241-008-22 Bottles of 100 NDC 72241-008-05 Bottles of 500 NDC 72241-008-10 Bottles of 1,000 NDC 72241-008-11
FLUOXETINE capsules USP, 40 mg* white to off white powder filled in size "0" hard gelatin capsules with green opaque cap and orange opaque body imprinted "C30" Bottles of 30 NDC 72241-009-22 Bottles of 100 NDC 72241-009-05 Bottles of 500 NDC 72241-009-10 *
FLUOXETINE base equivalent. Protect from light and preserve in tight containers. 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursion permitted to 15° to 30°C (59° to 86° F). [See USP Controlled Room Temperature]
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