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 Usp 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 Usp And Olanzapine In Combination Are Indicated For The Treatment Of: 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. 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 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 Usp And Olanzapine In Combination For Treatment Of: Acute Depressive Episodes Associated With Bipolar I Disorder ( 1)

All Formulated Excipients (5 Total)

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

Active Ingredients ( 1 Total)

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

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