Fluoxetine 40 MG Oral Capsule
1 INDICATIONS AND USAGE Fluoxetine capsules, USP 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, USP and Olanzapine in Combination are indicated for the treatment of: • Acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine capsules, USP monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine capsules, USP and olanzapine in combination, also refer to the Clinical Studies section of the package insert for olanzapine and fluoxetine hydrochloride capsules. Fluoxetine capsules, USP 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, USP and olanzapine in combination for treatment of: • Acute Depressive Episodes Associated with Bipolar I Disorder (1)
Sun Pharmaceutical Industries, Inc.
CAPSULE ORANGE RX632 RX632
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fluoxetine 40 MG as fluoxetine hydrochloride 44.8 MG Oral Capsule
Ranbaxy Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
FLUOXETINE capsules, USP 40 mg * are green opaque cap with orange opaque body, hard gelatin #2 capsules filled with white to off-white powder, imprinted with “ RX632 ” on the cap and body in black ink. They are available as follows: NDC 63304-632-30 Bottles of 30 NDC 63304-632-90 Bottles of 90 NDC 63304-632-01 Bottles of 100 NDC 63304-632-05 Bottles of 500 NDC 63304-632-10 Bottles of 1000 NDC 63304-632-80 Strip unit-dose pack of 100 *
FLUOXETINE base equivalent – present as the hydrochloride. Protect from light. Dispense in a tight, light-resistant container. 16.2 Storage and Handling Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].
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