paroxetine hydrochloride

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

paroxetine hydrochloride is listed in the FDA National Drug Code directory with 35 NDC codes, marketed under brand names including PAROXETINE, PAXIL, PAXIL CR. Available dosage forms: tablet, film coated, tablet, film coated, extended release, powder.

Drug Details

Generic Name
paroxetine hydrochloride
Brand Names
PAROXETINE, PAXIL, PAXIL CR, PAROXETINE HYDROCHLORIDE, paroxetine hydrochloride
Application Number
ANDA075356
Sponsor
REMEDYREPACK INC.
NDC Codes
35
Dosage Forms
TABLET, FILM COATED, TABLET, FILM COATED, EXTENDED RELEASE, POWDER
Routes
ORAL
Active Ingredients
PAROXETINE HYDROCHLORIDE ANHYDROUS, PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE

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 is 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)