Escitalopram Oral Solution

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Chartwell RX, LLC

DUNS Number

118673485

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

62135-729

Application Number

ANDA090477

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 1, 2023

Ingredients

SORBITOL SOLUTIONInactive

Code: 8KW3E207O2Class: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

Code: 5U85DBW7LOClass: ACTIMQuantity: 5 mg in 5 mL