Application Nr Approved Date Route Status External Links
ANDA206937 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fluoxetine Tablets, Usp Are Selective Serotonin Reuptake Inhibitor (Ssri) Indicated For The Treatment Of Premenstrual Dysphoric Disorder (Pmdd) (1.1) 1.1 Premenstrual Dysphoric Disorder (Pmdd) Fluoxetine Tablets, Usp Are Indicated For The Treatment Of Premenstrual Dysphoric Disorder (Pmdd) [See Clinical Studies (14.1)]. The Effectiveness Of Fluoxetine Tablets, Usp In Long-Term Use (That Is, For More Than 6 Months) Has Not Been Systematically Evaluated In Placebo-Controlled Trials. The Use Of Fluoxetine Tablets, Usp For Extended Periods Should Be Periodically Re-Evaluated For The Individual Patient [ See Dosage And Administration (2.1)].

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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