Application Nr Approved Date Route Status External Links
NDA204516 2013-06-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Brisdelle Is Indicated For The Treatment Of Moderate To Severe Vasomotor Symptoms (vms) Associated With Menopause. Limitation Of Use: Brisdelle Is Not Indicated For The Treatment Of Any Psychiatric Condition. Brisdelle Contains A Lower Dose Of Paroxetine Than That Used To Treat Depression, Obsessive Compulsive Disorder, Panic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, And Post-Traumatic Stress Disorder. The Safety And Efficacy Of This Lower Dose Of Paroxetine In Brisdelle Have Not Been Established For Any Psychiatric Condition. Patients Who Require Paroxetine For Treatment Of A Psychiatric Condition Should Discontinue Brisdelle And Initiate A Paroxetine-Containing Medication That Is Indicated For Such Use. Brisdelle Is A Selective Serotonin Reuptake Inhibitor (ssri) Indicated For The Treatment Of Moderate To Severe Vasomotor Symptoms Associated With Menopause (vms) ( 1) Limitation Of Use: Brisdelle Is Not Indicated For The Treatment Of Any Psychiatric Condition ( 1)

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. 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.
2. Gelatin GELATIN Unresolved
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
4. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Paroxetine Mesylate PAROXETINE MESYLATE ZINC527386

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