Escitalopram Oxalate

Basic Information

Product Name

FDA Product Code

17856-0551

Regulatory Information

NDC Product Code

17856-0551

Application Number

ANDA090477

Marketing Category

C73584

Effective Date

January 22, 2021

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use Escitalopram Oxalate Oral Solution safely and effectively. See full prescribing information for Escitalopram Oxalate Oral Solution. Escitalopram Oxalate Oral Solution Initial U.S. Approval: 2002

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

SORBITOL

Code: 506T60A25R

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

ESCITALOPRAM OXALATE

Quantity: 5 mg in 5 mL

Code: 5U85DBW7LO

Class Code: ACTIM

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

ESCITALOPRAM

Code: 4O4S742ANY

Basic Information

Regulatory Information

Company Information

Active Ingredients

SODIUM CITRATE

SORBITOL

ANHYDROUS CITRIC ACID

PROPYLENE GLYCOL

METHYLPARABEN

WATER

PROPYLPARABEN

GLYCERIN

Active Moieties

ESCITALOPRAM