Escitalopram Oxalate
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ESCITALOPRAM ORAL SOLUTION safely and effectively. See full prescribing information for ESCITALOPRAM ORAL SOLUTION. ESCITALOPRAM Oral Solution Initial U.S. Approval: 2002
Approved
Approval ID
82d793ee-4039-45fc-ac83-4bd5235f00aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2023
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Escitalopram Oxalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-569
Application NumberANDA202221
Product Classification
M
Marketing Category
C73584
G
Generic Name
Escitalopram Oxalate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2023
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 5 mg in 5 mL
Code: 5U85DBW7LO
Classification: ACTIM