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FDA Product

Escitalopram oxalate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Escitalopram oxalate

76282-250

Regulatory Information

76282-250

ANDA078604

C73584

September 1, 2023

USA

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 useInitial U.S. Approval: 2002

Human Prescription Drug Label

11

Company Information

967795266

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

ESCITALOPRAM OXALATE

Quantity: 10 mg in 1 1

Code: 5U85DBW7LO

Class Code: ACTIM

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

Active Moieties

ESCITALOPRAM

Code: 4O4S742ANY

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