Data updated: Mar 10, 2026
DULOXETINE HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE
Approved 2013-12-11
15
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-12-11
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS, CAPSULE, DELAYED RELEASE
Companies
TORRENT Teva PRINSTON INC SUNSHINE Sun Pharma ALEMBIC HETERO LABS LTD III YAOPHARMA CO LTD IMPAX LABS INC ZYDUS PHARMS Novartis MACLEODS PHARMS LTD ADAPTIS Apotex CSPC OUYI Lupin Aurobindo Pharma INVENTIA ZYDUS HLTHCARE PH HEALTH ALKEM LABS LTD AJANTA PHARMA LTD QINGDAO BAHEAL PHARM WOCKHARDT BRECKENRIDGE
Active Ingredient: DULOXETINE HYDROCHLORIDE
Website: ↗
DULOXETINE HYDROCHLORIDE Approval History
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What DULOXETINE HYDROCHLORIDE Treats
15 FDA approvalsOriginally approved for its first indication in 2013 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Dec 2013)Letter
- • Approved indication (Dec 2013)Letter
- • Approved indication (Jan 2014)Letter
- • Approved indication (Jun 2014)
- • Approved indication (Jun 2014)
- • Approved indication (Aug 2015)
- • Approved indication (Oct 2015)
- • Approved indication (Aug 2016)
- • Approved indication (Jan 2017)
- • Approved indication (Mar 2017)
- • Approved indication (May 2017)
- • Approved indication (Oct 2018)
- • Approved indication (Apr 2019)
- • Approved indication (Aug 2019)
- • Approved indication (Feb 2021)
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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.
DULOXETINE 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.