Application Nr Approved Date Route Status External Links
ANDA076001 2002-01-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluoxetine Capsules Are Indicated For The Treatment Of: Acute And Maintenance Treatment Of Major Depressive Disorder . • [see Clinical Studies ( )] 14.1 Acute And Maintenance Treatment Of Obsessions And Compulsions In Patients With Obsessive Compulsive Disorder (ocd) • [see Clinical Studies ( )]. 14.2 Acute And Maintenance Treatment Of Binge-Eating And Vomiting Behaviors In Patients With Moderate To Severe Bulimia Nervosa . • [see Clinical Studies ( )] 14.3 Acute Treatment Of Panic Disorder, With Or Without Agoraphobia • [see Clinical Studies ( )]. 14.4 Fluoxetine Capsules And Olanzapine In Combination Are Indicated For The Treatment Of: Acute Treatment Of Depressive Episodes Associated With Bipolar I Disorder. • Fluoxetine Capsules Monotherapy Is Not Indicated For The Treatment Of Depressive Episodes Associated With Bipolar I Disorder. When Using Fluoxetine Capsules And Olanzapine In Combination, Also Refer To The Clinical Studies Section Of The Package Insert For Symbyax . ® Fluoxetine Capsules Are A Selective Serotonin Reuptake Inhibitor Indicated For: Acute And Maintenance Treatment Of Major Depressive Disorder (mdd) ( ) • 1 Acute And Maintenance Treatment Of Obsessive Compulsive Disorder (ocd) ( ) • 1 Acute And Maintenance Treatment Of Bulimia Nervosa ( ) • 1 Acute Treatment Of Panic Disorder, With Or Without Agoraphobia ( ) • 1 Fluoxetine Capsules And Olanzapine In Combination For Treatment Of: Acute Depressive Episodes Associated With Bipolar I Disorder ( ) • 1

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. 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.
3. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

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

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