Escitalopram Oral

FDA Drug Profile — Escitalopram Oral Solution

Drug Details

Generic Name
Escitalopram Oral
Brand Names
Escitalopram Oral Solution
Application Number
ANDA090477
Sponsor
Chartwell RX, LLC
NDC Codes
2
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
ESCITALOPRAM OXALATE

Indications and Usage

1 INDICATIONS AND USAGE Escitalopram is indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s Lexapro (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of generalized anxiety disorder (GAD) in adults ( 1 )