Application Nr Approved Date Route Status External Links
NDA202133 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluoxetine 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 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 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fluoxetine Hydrochloride FLUOXETINE HYDROCHLORIDE ZINC1530637

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