Fluoxetine

Product manufactured by Proficient Rx Lp

Application Nr Approved Date Route Status External Links
ANDA076001 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluoxetine Capsules Usp Are A Selective Serotonin Reuptake Inhibitor Indicated For: • Acute And Maintenance Treatment Of Major Depressive Disorder (Mdd) In Adult And Pediatric Patients Aged 8 To 18 Years ( 1.1 ) • Acute And Maintenance Treatment Of Obsessive Compulsive Disorder (Ocd) In Adult And Pediatric Patients Aged 7 To 17 Years ( 1.2 ) • Acute And Maintenance Treatment Of Bulimia Nervosa In Adult Patients ( 1.3 ) • Acute Treatment Of Panic Disorder, With Or Without Agoraphobia, In Adult Patients ( 1.4 ) Fluoxetine Capsules Usp And Olanzapine In Combination For: • Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder ( 1.5 ) 1.1 Major Depressive Disorder Fluoxetine Capsules Usp Are Indicated For The Acute And Maintenance Treatment Of Major Depressive Disorder In Adult Patients And In Pediatric Patients Aged 8 To 18 Years [ See Clinical Studies ( 14.1 ) ] . The Usefulness Of The Drug In Adult And Pediatric Patients Receiving Fluoxetine For Extended Periods Should Periodically Be Re-Evaluated [ See Dosage And Administration ( 2.1 ) ] . 1.2 Obsessive Compulsive Disorder Fluoxetine Capsules Usp Are Indicated For The Acute And Maintenance Treatment Of Obsessions And Compulsions In Adult Patients And In Pediatric Patients Aged 7 To 17 Years With Obsessive Compulsive Disorder (Ocd) [ See Clinical Studies ( 14.2 ) ] . The Effectiveness Of Fluoxetine Capsules Usp In Long-Term Use, I.e., For More Than 13 Weeks, Has Not Been Systematically Evaluated In Placebo-Controlled Trials. Therefore, The Physician Who Elects To Use Fluoxetine Capsules Usp For Extended Periods, Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient [ See Dosage And Administration ( 2.2 ) ] . 1.3 Bulimia Nervosa Fluoxetine Capsules Usp Are Indicated For The Acute And Maintenance Treatment Of Binge-Eating And Vomiting Behaviors In Adult Patients With Moderate To Severe Bulimia Nervosa [ See Clinical Studies ( 14.3 ) ] . The Physician Who Elects To Use Fluoxetine Capsules Usp For Extended Periods Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient [ See Dosage And Administration ( 2.3 ) ] . 1.4 Panic Disorder Fluoxetine Capsules Usp Are Indicated For The Acute Treatment Of Panic Disorder, With Or Without Agoraphobia, In Adult Patients [ See Clinical Studies ( 14.4 ) ] . The Effectiveness Of Fluoxetine Capsules Usp In Long-Term Use, I.e., For More Than 12 Weeks, Has Not Been Established In Placebo-Controlled Trials. Therefore, The Physician Who Elects To Use Fluoxetine Capsules Usp For Extended Periods, Should Periodically Re-Evaluate The Long-Term Usefulness Of The Drug For The Individual Patient [ See Dosage And Administration ( 2.4 ) ]. 1.5 Fluoxetine Capsules Usp And Olanzapine In Combination: Depressive Episodes Associated With Bipolar I Disorder When Using Fluoxetine Capsules Usp And Olanzapine In Combination, Also Refer To The Clinical Studies Section Of The Package Insert For Symbyax ® . Fluoxetine Capsules Usp And Olanzapine In Combination Is Indicated For The Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder. Fluoxetine Capsules Usp Monotherapy Is Not Indicated For The Treatment Of Depressive Episodes Associated With Bipolar I Disorder.

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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