Fluoxetine 60 MG Oral Tablet
1 INDICATIONS AND USAGE Fluoxetine Tablets is indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see CLINICAL STUDIES ( 14.1 )]. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see CLINICAL STUDIES ( 14.2 )]. Binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. The efficacy of fluoxetine in Bulimia Nervosa was demonstrated in two 8-week trials and one 16-week trial in adults [see CLINICAL STUDIES ( 14.3 )]. Panic Disorder, with or without agoraphobia. The efficacy of fluoxetine in Panic Disorder was demonstrated in two 12-week trials in adults [see CLINICAL STUDIES ( 14.4 )]. Fluoxetine tablets is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: Major Depressive Disorder (MDD) ( 1 ) Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study ( 14.1 ) Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age ( 14.1 ) Obsessive Compulsive Disorder (OCD) ( 1 ) Adults: Efficacy was established in two 13-week trials ( 14.2 ) Pediatrics: Efficacy was established in one 13-week trial in patients 7 to 17 years of age ( 14.2 ) Bulimia Nervosa ( 1 ) Adults: Efficacy was established in two 8-week trials and one 16-week trial ( 14.3 ) Panic Disorder, with or without agoraphobia ( 1 ) Adults: Efficacy was established in two 12-week trials ( 14.4 )
Lupin Pharmaceuticals, Inc.
OVAL WHITE L U F57
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine tablets USP, 60 mg, are available as 60-mg, white to off-white film-coated, functional-scored, modified capsule shaped tablet, debossed with "L" on the left of the score and "U" on the right of the score on one side of the tablet and "F57" on the left of the score and plain on the right of the score on other side in bottles of 30 tablets (NDC 68180-997-06). 16.2 Storage and Handling Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Preserve in tight containers.
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