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paroxetine hydrochloride hemihydrate

FDA Drug Profile — Paroxetine

Drug Details

Generic Name
paroxetine hydrochloride hemihydrate
Brand Names
Paroxetine
Application Number
ANDA203854
Sponsor
REMEDYREPACK INC.
NDC Codes
30
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE ANHYDROUS

Indications and Usage

1 INDICATIONS AND USAGE Paroxetine tablets are indicated in adults for the treatment of: • Major depressive disorder (MDD) • Obsessive compulsive disorder (OCD) • Panic disorder (PD) • Social anxiety disorder (SAD) • Generalized anxiety disorder (GAD) • Posttraumatic stress disorder (PTSD) Paroxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ): • Major Depressive Disorder (MDD) • Obsessive Compulsive Disorder (OCD) • Panic Disorder (PD) • Social Anxiety Disorder (SAD) • Generalized Anxiety Disorder (GAD) • Posttraumatic Stress Disorder (PTSD)