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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