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 Paroxetine Capsules Are Indicated For The Treatment Of Moderate To Severe Vasomotor Symptoms (vms) Associated With Menopause. Limitation Of Use: Paroxetine Capsules Are Not Indicated For The Treatment Of Any Psychiatric Condition. Paroxetine Capsules Contain 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 Paroxetine Capsules Have Not Been Established For Any Psychiatric Condition. Patients Who Require Paroxetine For Treatment Of A Psychiatric Condition Should Discontinue Paroxetine Capsules And Initiate A Paroxetine-Containing Medication That Is Indicated For Such Use. •paroxetine Capsules Are A Selective Serotonin Reuptake Inhibitor (ssri) Indicated For The Treatment Of Moderate To Severe Vasomotor Symptoms Associated With Menopause (vms) (1) Limitation Of Use: Paroxetine Capsules Are 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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