Fluoxetine 10 MG Oral Capsule
1 INDICATIONS & 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. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine 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 )
Camber Pharmaceuticals, Inc.
CAPSULE ORANGE SG 113
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine capsules, USP 10 mg ** are white to off white powder filled in size "4" hard gelatin capsules with opaque light blue colored cap and opaque light orange colored body imprinted "SG" on cap and "113" on body with black ink. Bottles of 30 NDC 31722-903-30 Bottles of 100 NDC 31722-903-01 Bottles of 500 NDC 31722-903-05 Bottles of 1000 NDC 31722-903-10 Fluoxetine capsules USP, 20 mg ** are white to off white powder filled in size "2"hard gelatin capsules with opaque light blue colored cap and opaque light green colored body imprinted "SG"on cap and "114" on body with black ink. Bottles of 30 NDC 31722-904-30 Bottles of 100 NDC 31722-904-01 Bottles of 500 NDC 31722-904-05 Bottles of 1000 NDC 31722-904-10 Fluoxetine capsules USP, 40 mg ** are white to off white powder filled in size "0" hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted "SG" on cap and "115" on body with black ink. Bottles of 30 NDC 31722-905-30 Bottles of 100 NDC 31722-905-01 Bottles of 500 NDC 31722-905-05 ** Fluoxetine base equivalent. 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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