Application Nr Approved Date Route Status External Links
ANDA091482 2013-11-18 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluvoxamine Maleate Extended-Release Capsules Are A Selective Serotonin Reuptake Inhibitor (ssri) Indicated For The Treatment Of Obsessive Compulsive Disorder (ocd) (1). Efficacy Was Demonstrated In: One 12-Week Study With Fluvoxamine Maleate Extended-Release Capsules In Adults (14.1). Two 10-Week Studies With Immediate-Release (ir) Fluvoxamine Tablets In Adults And One 10-Week Study With Ir Fluvoxamine Tablets In Children And Adolescents (14.1, 14.3). One Maintenance Study With Ir Fluvoxamine Tablets (14.2). 1.1 Obsessive Compulsive Disorder Fluvoxamine Maleate Extended-Release Capsules Are Indicated For The Treatment Of Obsessive Compulsive Disorder (ocd), As Defined In The Dsm-Iv. 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 Obsessions Or Compulsions Cause Marked Distress, Are Time-Consuming, Or Significantly Interfere With Social Or Occupational Functioning. The Efficacy Of Fluvoxamine Maleate Extended-Release Capsules Was Demonstrated In One 12-Week Trial In Adults With Fluvoxamine Maleate Extended-Release Capsules As Well As In Two 10-Week Trials In Adults And In One 10-Week Trial In Children And Adolescents (ages 8 To 17 Years) With Immediate-Release Fluvoxamine Tablets In Outpatients With The Diagnosis Of Ocd As Defined In Dsm-Iv Or Dsm-Iii-R (see Clinical Studies [14.1, 14.3]). The Efficacy Of Fluvoxamine For Long-Term Use Was Established In One Maintenance Study In Adults With Immediate-Release Fluvoxamine Tablets (see Clinical Studies [14.2]). The Health Care Provider Who Elects To Prescribe Fluvoxamine Maleate Extended-Release Capsules For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration [2.4]).

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ammonio Methacrylate Copolymer AMMONIO METHACRYLATE COPOLYMER Unresolved
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Gelatin GELATIN Unresolved
4. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
6. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
7. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
8. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluvoxamine Maleate FLUVOXAMINE MALEATE ZINC3872605

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