fluoxetine 20 mg
1 INDICATIONS AND 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 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 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 and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ® . Fluoxetine Capsules 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 ( 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 )
Heritage Pharmaceuticals Inc. d/b/a Avet Phar
CAPSULE YELLOW HP 29
HP 29 CAPSULE YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied The following products are manufactured for Avet Pharmaceuticals Inc.: capsules are available in 10 mg, 20 mg and 40 mg capsule strengths and packages as follows: 1
FLUOXETINE base equivalent. 2 Protect from light. capsule Strength 10 mg 1,2 20 mg 1,2 40 mg 1,2 Cap Color Opaque green Opaque green Opaque green Body Color Opaque green Opaque yellow Opaque orange Identification HP28 HP29 HP30 NDC Codes: Bottles of 30 23155-030-03 Bottles of 100 23155-028-01 23155-029-01 23155-030-01 Bottles of 500 23155-030-05 Bottles of 1000 23155-028-10 23155-029-10 23155-030-10 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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