fluoxetine hcl
Drug Details
- Generic Name
- fluoxetine hcl
- Brand Names
- FLUOXETINE HCL
- Application Number
- ANDA212683
- Sponsor
- Strides Pharma Science Limited
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- FLUOXETINE
Indications and Usage
1 INDICATIONS AND USAGE Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine tablets in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine tablets 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 tablets 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 tablets 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 tablets 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)