Sarafem

Product manufactured by Allergan, Inc.

Application Nr Approved Date Route Status External Links
NDA021860 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Sarafem Is A Selective Serotonin Reuptake Inhibitor (Ssri) Indicated For The Treatment Of Premenstrual Dysphoric Disorder (Pmdd) ( 1.1 ) 1.1 Premenstrual Dysphoric Disorder (Pmdd) Sarafem Is Indicated For The Treatment Of Premenstrual Dysphoric Disorder (Pmdd) [See Clinical Studies (14.1) ]. The Effectiveness Of Sarafem In Long-Term Use (That Is, For More Than 6 Months) Has Not Been Systematically Evaluated In Placebo-Controlled Trials. The Use Of Sarafem 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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