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Escitalopram

These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

Approved
Approval ID

c9f52332-8616-19d8-e053-2995a90ad753

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 27, 2023

Manufacturers
FDA

Northwind Pharmaceuticals, LLC

DUNS: 036986393

Products 1

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

Escitalopram

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51655-449
Application NumberANDA202389
Product Classification
M
Marketing Category
C73584
G
Generic Name
Escitalopram
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2023
FDA Product Classification

INGREDIENTS (7)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM

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Escitalopram - FDA Drug Approval Details