Tools / Drug approvals and letters / Drugs Citalopram Hydrobromide Treats major depressive disorder (MDD). Sold as Celexa, Citalopram Hydrobromide. Every FDA application for this active ingredient: 4 branded and 33 generic.
As of Nov 15, 2026, FDA lists 37 applications for Citalopram Hydrobromide (sold as Celexa, Citalopram Hydrobromide), first approved Jul 17, 1998, with 0 new uses approved and 0 published complete response letters.
First approved : Jul 17, 1998 Applications : 37 New uses approved : 0 Complete response letters : 0 Medicare spending, 2025 : $54.6M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Citalopram HBr Part D $52.2M +7% 1,370,173 Celexa Part D $2.3M -8% 881
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change CELEXA 20 MG TABLET: $9.04 per unit Brand · 0% in a year CELEXA 40 MG TABLET: $9.47 per unit Brand · +0% in a year Clinical Trials 15 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Biomarkers and Pharmacogenomics for Precision Depression Therapy Depression / Major Depressive Disorder · The Fourth Affiliated Hospital of Zhejiang University School of Medicine Not applicable Not yet recruiting Jul 31, 2026 Citalopram and the Risk of Serious Adverse Events Chronic Kidney Disease (CKD), Elderly · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's — Active, not recruiting Feb 10, 2026 Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. Treatment Resistant Schizophrenia, Treatment Resistant Bipolar Disorder · Dr. Stavroula Rakitzi Phase 4 Active, not recruiting Jul 2, 2025 Pupillometry in Delayed Sleep Wake Phase Disorder Delayed Sleep-Wake Phase Disorder · Northwestern University Not applicable Recruiting Apr 29, 2025 Deprescription of Antidepressants in Primary Care (DAPriCare) Deprescription, Antidepressants · University of Huelva Early phase 1 Not yet recruiting Jan 28, 2025 Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients Depressed Insomniac Co-morbid Patients · Tongji University Phase 4 Recruiting Dec 18, 2024 Clemastine for Improving White Matter and Boosting Antidepressant Response in Late-life Depression Depression · University of Illinois Chicago Phase 2 Recruiting Sep 19, 2024 7T Amygdala and Citalopram Study Emotional Processing, Cognition · University of Oxford Not applicable Recruiting May 14, 2024
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Jul 17, 1998 Celexa NDA 20822 · New molecular entity 33 Marketed Dec 22, 1999 Celexa NDA 21046 · New dosage form 12 Discontinued Oct 28, 2004 Citalopram Hydrobromide ANDA 77033 3 Discontinued Oct 28, 2004 Citalopram Hydrobromide ANDA 77038 13 Marketed Oct 28, 2004 Citalopram Hydrobromide ANDA 77031 20 Marketed Oct 28, 2004 Citalopram Hydrobromide ANDA 77035 9 Discontinued Oct 28, 2004 Citalopram Hydrobromide ANDA 77036 8 Discontinued Nov 5, 2004 Citalopram Hydrobromide ANDA 77042 17 Marketed Nov 5, 2004 Citalopram Hydrobromide ANDA 77037 8 Discontinued Nov 5, 2004 Citalopram Hydrobromide ANDA 77044 8 Marketed Nov 12, 2004 Citalopram Hydrobromide ANDA 77032 14 Discontinued Nov 16, 2004 Citalopram Hydrobromide ANDA 77048 12 Discontinued Nov 23, 2004 Citalopram Hydrobromide ANDA 77041 0 Discontinued Nov 24, 2004 Citalopram Hydrobromide ANDA 77046 15 Discontinued Dec 13, 2004 Citalopram Hydrobromide ANDA 77043 13 Marketed Feb 3, 2005 Citalopram Hydrobromide ANDA 77039 6 Discontinued Apr 29, 2005 Citalopram Hydrobromide ANDA 77045 7 Marketed Jun 30, 2005 Citalopram Hydrobromide ANDA 77034 4 Discontinued Aug 17, 2005 Citalopram Hydrobromide ANDA 77040 1 Discontinued Oct 31, 2005 Citalopram Hydrobromide ANDA 77232 3 Discontinued Nov 15, 2005 Citalopram Hydrobromide ANDA 77601 7 Discontinued Dec 20, 2005 Citalopram Hydrobromide NDA 21763 · New dosage form 0 Marketed Mar 22, 2006 Citalopram Hydrobromide ANDA 77278 2 Discontinued Mar 31, 2006 Citalopram Hydrobromide ANDA 77213 3 Discontinued Jun 14, 2006 Citalopram Hydrobromide ANDA 77629 13 Marketed Jul 3, 2006 Citalopram Hydrobromide ANDA 77052 1 Discontinued Aug 28, 2006 Citalopram Hydrobromide ANDA 77812 13 Marketed Oct 3, 2006 Citalopram Hydrobromide ANDA 77534 12 Marketed Nov 30, 2006 Citalopram Hydrobromide ANDA 77289 14 Discontinued Feb 28, 2007 Citalopram Hydrobromide ANDA 77668 6 Discontinued Mar 27, 2007 Citalopram Hydrobromide ANDA 78216 16 Marketed Apr 10, 2008 Citalopram Hydrobromide ANDA 77141 3 Discontinued Feb 27, 2009 Citalopram Hydrobromide ANDA 77654 5 Discontinued Dec 15, 2015 Citalopram Hydrobromide ANDA 201450 4 Marketed Dec 23, 2015 Citalopram Hydrobromide ANDA 205407 3 Discontinued Jan 31, 2022 Citalopram Hydrobromide NDA 215428 · TYPE 2/3 1 Marketed Mar 13, 2026 Citalopram Hydrobromide ANDA 219985 0 Marketed
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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