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escitalopram oxalate

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 USP, for oral use Initial U.S. Approval: 2002

Approved
Approval ID

643dbe13-a06c-0d18-e053-2991aa0aa1bc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 3, 2022

Manufacturers
FDA

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

DUNS: 080355546

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 Code70934-060
Application NumberANDA090939
Product Classification
M
Marketing Category
C73584
G
Generic Name
escitalopram oxalate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2022
FDA Product Classification

INGREDIENTS (10)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ESCITALOPRAM OXALATEActive
Quantity: 10 mg in 1 1
Code: 5U85DBW7LO
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT

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escitalopram oxalate - FDA Drug Approval Details