Sertraline

FDA Drug Profile — Sertraline, SERTRALINE, Sertraline HCl

Drug Details

Generic Name
Sertraline
Brand Names
Sertraline, SERTRALINE, Sertraline HCl
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 tablet is 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)