sertraline hydrochloride

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

sertraline hydrochloride is listed in the FDA National Drug Code directory with 29 NDC codes, marketed under brand names including SERTRALINE HYDROCHLORIDE, Zoloft, sertraline HCl. Available dosage forms: tablet, tablet, film coated, solution, concentrate, capsule.

Drug Details

Generic Name
sertraline hydrochloride
Brand Names
SERTRALINE HYDROCHLORIDE, Zoloft, sertraline HCl, sertraline hydrochloride
Application Number
ANDA214790
Sponsor
Camber Pharmaceuticals, Inc.
NDC Codes
29
Dosage Forms
TABLET, TABLET, FILM COATED, SOLUTION, CONCENTRATE, CAPSULE
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) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)