Sertraline

FDA Drug Profile — Sertraline, Sertraline HCl, SERTRALINE

Drug Details

Generic Name
Sertraline
Brand Names
Sertraline, Sertraline HCl, SERTRALINE
Application Number
ANDA076465
Sponsor
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC Codes
37
Dosage Forms
TABLET, FILM COATED, POWDER, CAPSULE
Routes
ORAL
Active Ingredients
SERTRALINE HYDROCHLORIDE, SERTRALINE

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)