Sertraline

FDA Drug Profile — Sertraline HCl, Sertraline, SERTRALINE

Sertraline is listed in the FDA National Drug Code directory with 38 NDC codes, marketed under brand names including Sertraline HCl, Sertraline, SERTRALINE. Available dosage forms: capsule, powder, tablet, film coated.

Drug Details

Generic Name
Sertraline
Brand Names
Sertraline HCl, Sertraline, SERTRALINE
Application Number
ANDA219655
Sponsor
Amneal Pharmaceuticals NY LLC
NDC Codes
38
Dosage Forms
CAPSULE, POWDER, TABLET, FILM COATED
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) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)