This site is intended for healthcare professionals
Abstract digital waveforms in blue and purple
FDA Drug information

Escitalopram

Read time: 1 mins
Marketing start date: 26 Nov 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.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.

Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.