Data updated: Mar 10, 2026
CITALOPRAM HYDROBROMIDE
CITALOPRAM HYDROBROMIDE
Approved 2004-10-28
28
Indications
--
Phase 3 Trials
21
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2004-10-28
- Routes
- ORAL, ORALLY DISINTEGRATING
- Dosage Forms
- TABLET, SOLUTION, TABLET, ORALLY DISINTEGRATING, CAPSULE
Companies
FOSUN PHARMA EPIC PHARMA Aurobindo Pharma Hikma HERITAGE PHARMA ROXANE Sun Pharma JUBILANT GENERICS PHARMOBEDIENT Viatris BIOVAIL LABS INTL EPIC PHARMA LLC NATCO PHARMA LTD CHARTWELL MOLECULAR Apotex COSETTE Dr. Reddy's TARO GLENMARK PHARMS LTD PHARM ASSOC HETERO LABS LTD III ALMATICA CHARTWELL RX AMNEAL PHARMS NY INVAGEN PHARMS TORRENT PHARMS
Active Ingredient: CITALOPRAM HYDROBROMIDE
Website: ↗
CITALOPRAM HYDROBROMIDE Approval History
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What CITALOPRAM HYDROBROMIDE Treats
28 FDA approvalsOriginally approved for its first indication in 2004 . Covers 28 distinct patient populations.
- Other (28)
Other
(28 approvals)- • Approved indication (Oct 2004)Letter
- • Approved indication (Nov 2004)
- • Approved indication (Nov 2004)
- • Approved indication (Nov 2004)
- • Approved indication (Nov 2004)
- • Approved indication (Nov 2004)
- • Approved indication (Dec 2004)Letter
- • Approved indication (Feb 2005)Letter
- • Approved indication (Apr 2005)
- • Approved indication (Jun 2005)
- • Approved indication (Aug 2005)
- • Approved indication (Oct 2005)
- • Approved indication (Nov 2005)
- • Approved indication (Dec 2005)Label Letter
- • Approved indication (Mar 2006)
- • Approved indication (Mar 2006)
- • Approved indication (Jun 2006)
- • Approved indication (Jul 2006)
- • Approved indication (Aug 2006)
- • Approved indication (Oct 2006)
- • Approved indication (Nov 2006)
- • Approved indication (Feb 2007)
- • Approved indication (Mar 2007)
- • Approved indication (Apr 2008)
- • Approved indication (Feb 2009)
- • Approved indication (Dec 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Jan 2022)Label Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CITALOPRAM HYDROBROMIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.