Fluoxetine 40 MG Oral Capsule
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 in adult. 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 Symbya ® . 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 (1) • Acute treatment of Panic Disorder, with or without agoraphobia(1) Fluoxetine and olanzapine in combination for treatment of: • Acute treatment of Depressive Episodes Associated with Bipolar I Disorder in adults (1)
alembic pharmaceuticals limited
CAPSULE BLUE 40 A107
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Alembic Pharmaceuticals Limited
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16. HOW SUPPLIED/STORAGE AND HANDLING 16.1. How Supplied The following products are manufactured by Alembic Pharmaceuticals Limited, India.
FLUOXETINE capsules USP, are available in: The 10-mg 1 , capsule is blue opaque cap and white opaque body, imprinted with “10” on the cap and “A105” on the body: NDC 46708-271-30- Bottles of 30 2 NDC 46708-271-31- Bottles of 100 2 NDC 46708-271-71- Bottles of 500 2 NDC 46708-271-91 - Bottles of 1000 2 The 20-mg 1 , capsule is a Dark blue opaque cap and Light blue opaque body, imprinted with “20” on the cap and “A106” on the body: NDC 46708-272-30- Bottles of 30 2 NDC 46708-272-31- Bottles of 100 2 NDC 46708-272-71- Bottles of 500 2 NDC 46708-272-91 - Bottles of 1000 2 The 40-mg 1 , capsule is a Light blue opaque cap and Light blue opaque body, imprinted with “40” on the cap and “A107” on the body: NDC 46708-273-30- Bottles of 30 2 NDC 46708-273-31 - Bottles of 100 2 NDC 46708-273-71- Bottles of 500 2 NDC 46708-273-91- Bottles of 1000 2 _____________________________ 1
FLUOXETINE base equivalent 2 Protect from light. 16.2. Storage and Handling Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59 to 86ºF), (See USP Controlled Room Temperature).
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