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sertraline hydrochloride

FDA Drug Profile — sertraline hydrochloride, SERTRALINE HYDROCHLORIDE, Zoloft, sertraline HCl

Drug Details

Generic Name
sertraline hydrochloride
Brand Names
sertraline hydrochloride, SERTRALINE HYDROCHLORIDE, Zoloft, sertraline HCl
Application Number
NDA215133
Sponsor
Alvogen, Inc.
NDC Codes
29
Dosage Forms
CAPSULE, TABLET, FILM COATED, SOLUTION, CONCENTRATE, TABLET
Routes
ORAL
Active Ingredients
SERTRALINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14) ] : • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Post-traumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD)