Sertraline

FDA Drug Profile — Sertraline, Sertraline HCl, SERTRALINE

Sertraline is listed in the FDA National Drug Code directory with 39 NDC codes, marketed under brand names including Sertraline, Sertraline HCl, SERTRALINE. Available dosage forms: tablet, film coated, capsule, powder.

Drug Details

Generic Name
Sertraline
Brand Names
Sertraline, Sertraline HCl, SERTRALINE
Application Number
ANDA077670
Sponsor
A-S Medication Solutions
NDC Codes
39
Dosage Forms
TABLET, FILM COATED, CAPSULE, POWDER
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)