paroxetine hydrochloride

FDA Drug Profile — PAXIL CR, paroxetine hydrochloride, PAROXETINE, PAXIL, PAROXETINE HYDROCHLORIDE

Drug Details

Generic Name
paroxetine hydrochloride
Brand Names
PAXIL CR, paroxetine hydrochloride, PAROXETINE, PAXIL, PAROXETINE HYDROCHLORIDE
Application Number
NDA020936
Sponsor
Apotex Corp
NDC Codes
33
Dosage Forms
TABLET, FILM COATED, EXTENDED RELEASE, TABLET, FILM COATED, POWDER
Routes
ORAL
Active Ingredients
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, 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)