sertraline hydrochloride

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

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

Drug Details

Generic Name
sertraline hydrochloride
Brand Names
Zoloft, SERTRALINE HYDROCHLORIDE, sertraline hydrochloride, sertraline HCl
Application Number
NDA019839
Sponsor
ROERIG
NDC Codes
29
Dosage Forms
TABLET, FILM COATED, TABLET, CAPSULE, SOLUTION, CONCENTRATE
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)