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FDA Drug information

Escitalopram

Read time: 1 mins
Marketing start date: 02 May 2024

Summary of product characteristics


Effective Time

20221105

Version

4

Spl Product Data Elements

escitalopram escitalopram ESCITALOPRAM OXALATE ESCITALOPRAM SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC;37 escitalopram escitalopram ESCITALOPRAM OXALATE ESCITALOPRAM SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC;23 escitalopram escitalopram ESCITALOPRAM OXALATE ESCITALOPRAM SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED WHITE TO OFF-WHITE ROUND ZC;24

Application Number

ANDA077734

Brand Name

Escitalopram

Generic Name

escitalopram

Product Ndc

70771-1147

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1145-9 in bottle of 90 tablets Escitalopram Oxalate Tablets USP, 5 mg R x only 90 tablets NDC 70771-1146-9 in bottle of 90 tablets Escitalopram Oxalate Tablets USP, 10 mg R x only 90 tablets NDC 70771-1147-9 in bottle of 90 tablets Escitalopram Oxalate Tablets USP, 20 mg R x only 90 tablets Escitalopram Oxalate Tablets, 5 mg Escitalopram Oxalate Tablets, 10 mg Escitalopram Oxalate Tablets, 20 mg

Spl Medguide

SPL MEDGUIDE Manufactured by: Cadila Healthcare Ltd. India.

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