fluoxetine tablet film coated
1 INDICATIONS AND USAGE Fluoxetine tablets are 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 are 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 )
teva pharmaceuticals usa, inc.
OVAL WHITE TE VA 52 62
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Fluoxetine tablets USP, 60 mg, are available as 60 mg (fluoxetine base equivalent), white, film-coated, modified capsule-shaped, functional-scored tablet, scored and debossed with “TE|VA” on one side of the tablet. The other side of the tablet is scored and debossed with “52|62” in bottles of 30s (NDC 0093-5262-56). 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light.
More pills like OVAL TE VA 52 62