MedPath

Citalopram

Generic Name
Citalopram
Brand Names
Celexa, Ctp
Drug Type
Small Molecule
Chemical Formula
C20H21FN2O
CAS Number
59729-33-8
Unique Ingredient Identifier
0DHU5B8D6V

Overview

Citalopram is an antidepressant belonging to the class of selective serotonin-reuptake inhibitors (SSRIs) widely used to treat the symptoms of depression. It is a racemic bicyclic phthalate derivate and is the only compound with a tertiary amine and 2 nitrogen-containing metabolites among all SSRIs. Citalopram enhances serotonergic transmission through the inhibition of serotonin reuptake, and among all the SSRIs, citalopram appears to be the most selective toward serotonin reuptake inhibition. Specifically, it has a very minimal effect on dopamine and norepinephrine transportation and virtually no affinity for muscarinic, histaminergic, or GABAergic receptors. Citalopram was approved by the FDA in 1998 for the treatment of depression in adults 18 years or older.

Indication

Citalopram is approved by the FDA for treating adults with major depressive disorder. It has also been used off-label to treat various diseases, including but not limited to sexual dysfunction, ethanol abuse, psychiatric conditions such as obsessive-compulsive disorder (OCD), social anxiety disorder, panic disorder, and diabetic neuropathy.

Associated Conditions

  • Alcohol Abuse
  • Anorexia Nervosa (AN)
  • Binge Eating Disorder (BED)
  • Bulimia Nervosa
  • Depression
  • Diabetic Neuropathies
  • Generalized Anxiety Disorder
  • Major Depressive Disorder (MDD)
  • Obsessive Compulsive Disorder (OCD)
  • Panic Disorder
  • Post Traumatic Stress Disorder (PTSD)
  • Premature Ejaculation
  • Premenstrual Dysphoric Disorder (PMDD)
  • Separation Anxiety Disorder
  • Social Anxiety Disorder (SAD)

Research Report

Published: Jul 30, 2025

A Comprehensive Clinical and Pharmacological Review of Citalopram (DB00215)

1.0 Introduction and Drug Identification

1.1 Overview and Classification

Citalopram is a widely prescribed antidepressant medication belonging to the class of selective serotonin reuptake inhibitors (SSRIs).[1] As a small molecule drug, its primary therapeutic application is in the management of major depressive disorder and other mood-related conditions.[1] A defining feature of citalopram is its pharmacological profile; among all SSRIs, it is recognized as one of the most selective inhibitors of serotonin reuptake, a characteristic that fundamentally shapes its clinical efficacy and tolerability.[1]

The global significance of citalopram in mental healthcare is underscored by its inclusion in the World Health Organization (WHO) Model List of Essential Medicines for the treatment of depressive disorders.[2] Its extensive clinical use is further highlighted by prescription statistics; in 2022, it was the 40th most commonly prescribed medication in the United States, accounting for over 15 million prescriptions.[3]

1.2 Historical Development and Regulatory Milestones

The journey of citalopram from laboratory synthesis to a cornerstone of depression treatment illustrates key trends in pharmaceutical development and public health. The molecule was first synthesized in 1972 by the Danish pharmaceutical company Lundbeck, which subsequently patented the compound.[4] The path to market was protracted, involving a rigorous 15-year period of development and clinical trials to establish its efficacy and safety profile.[4] This lengthy timeline is not unusual for neuropsychiatric agents, where demonstrating a clear therapeutic benefit against a complex and variable disease background presents significant scientific and regulatory challenges.

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
DIRECT RX
61919-055
ORAL
10 mg in 1 1
1/22/2020
DIRECT RX
61919-288
ORAL
10 mg in 1 1
4/12/2016
Quality Care Products, LLC
55700-838
ORAL
40 mg in 1 1
1/30/2020
QUALLENT PHARMACEUTICALS HEALTH LLC
82009-107
ORAL
20 mg in 1 1
10/5/2023
Aurobindo Pharma Limited
65862-074
ORAL
10 mg in 5 mL
8/24/2023
State of Florida DOH Central Pharmacy
53808-1037
ORAL
40 mg in 1 1
9/30/2014
Apotheca Inc.
12634-629
ORAL
10 mg in 1 1
6/17/2016
QUALLENT PHARMACEUTICALS HEALTH LLC
82009-108
ORAL
40 mg in 1 1
10/5/2023
NuCare Pharmaceuticals,Inc.
68071-1830
ORAL
20 mg in 1 1
6/24/2021
State of Florida DOH Central Pharmacy
53808-1077
ORAL
40 mg in 1 1
12/30/2014

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
PRISDAL 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
Lundbeck Espana S.A.
60884
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
CITALOPRAM TEVA-RATIOPHARM 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Teva Pharma S.L.U.
67581
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized
SEREGRA 20 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Arafarma Group S.A.
69163
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
SEREGRA 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Arafarma Group S.A.
69164
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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