Data updated: Mar 10, 2026
PAROXETINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE
Approved 2003-07-30
21
Indications
--
Phase 3 Trials
22
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2003-07-30
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE, SUSPENSION
Companies
ROXANE Lupin Aurobindo Pharma OXFORD PHARMS ZYDUS PHARMS USA CADILA PHARMS LTD CHARTWELL RX Teva Sun Pharma SCIECURE PHARMA INC YILING Apotex UPSHER SMITH LABS Viatris CSPC OUYI EPIC PHARMA LLC NOVITIUM PHARMA PHARMOBEDIENT LANNETT CO INC JUBILANT GENERICS PRINSTON INC ALEMBIC
Active Ingredient: PAROXETINE HYDROCHLORIDE
Website: ↗
PAROXETINE HYDROCHLORIDE Approval History
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What PAROXETINE HYDROCHLORIDE Treats
21 FDA approvalsOriginally approved for its first indication in 2003 . Covers 21 distinct patient populations.
- Other (21)
Other
(21 approvals)- • Approved indication (Jul 2003)Letter
- • Approved indication (Mar 2004)
- • Approved indication (Aug 2005)
- • Approved indication (Dec 2006)
- • Approved indication (Mar 2007)
- • Approved indication (Jun 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Jun 2010)
- • Approved indication (Apr 2011)
- • Approved indication (Nov 2015)
- • Approved indication (Jun 2016)
- • Approved indication (Jan 2017)
- • Approved indication (Jun 2018)
- • Approved indication (Feb 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Sep 2021)Letter
- • Approved indication (Nov 2021)
- • Approved indication (Jan 2024)
- • Approved indication (Sep 2025) New
🔬
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.
PAROXETINE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.