Fluvoxamine maleate
Fluvoxamine maleate is listed in the FDA National Drug Code directory with 18 NDC codes, marketed under brand names including Fluvoxamine maleate, fluvoxamine maleate. Available dosage forms: tablet, film coated, tablet, coated, tablet.
Drug Details
- Generic Name
- Fluvoxamine maleate
- Brand Names
- Fluvoxamine maleate, fluvoxamine maleate
- Application Number
- ANDA075888
- Sponsor
- Upsher-Smith Laboratories, LLC
- NDC Codes
- 18
- Dosage Forms
- TABLET, FILM COATED, TABLET, COATED, TABLET
- Routes
- ORAL
- Active Ingredients
- FLUVOXAMINE MALEATE
Indications and Usage
1 INDICATIONS AND USAGE Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) (1) . 1.1 Obsessive-Compulsive Disorder Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 to 17), and one maintenance trial in adults [see Clinical Studies (14) ].