Application Nr Approved Date Route Status External Links
ANDA075245 2004-09-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluoxetine Is 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 And Olanzapine In Combination For: • Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder In Adults (1.5) 1.1 Major Depressive Disorder Fluoxetine Is Indicated For The Acute And Maintenance Treatment Of Major Depressive Disorder In Adult Patients And In Pediatric Patients Aged 8 To18 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 Is 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 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 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 Is 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 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 Is Indicated For The Acute Treatment Of Panic Disorder, With Or Without Agoraphobia, In Adult Patients [see Clinical Studies (14.4)]. The Effectiveness Of Fluoxetine 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 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 And Olanzapine In Combination: Depressive Episodes Associated With Bipolar I Disorder When Using Fluoxetine And Olanzapine In Combination, Also Refer To The Clinical Studies Section Of The Package Insert For Olanzapine And Fluoxetine Hydrochloride Capsules. Fluoxetine And Olanzapine In Combination Is Indicated For The Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder In Adult Patients. Fluoxetine Monotherapy Is Not Indicated For The Treatment Of Depressive Episodes Associated With Bipolar I Disorder.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Starch, Corn STARCH, CORN Unresolved
4. Gelatin GELATIN Unresolved
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. 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.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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