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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

f1b7c316-a499-4060-89e8-c5210f331ef5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2023

Manufacturers
FDA

RPK Pharmaceuticals, Inc.

DUNS: 147096275

Products 1

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

Escitalopram

PRODUCT DETAILS

NDC Product Code53002-1431
Application NumberANDA202389
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 17, 2022
Generic NameEscitalopram

INGREDIENTS (7)

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

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Escitalopram - FDA Drug Approval Details