Data updated: Mar 10, 2026
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE
Approved 2004-02-06
47
Indications
--
Phase 3 Trials
22
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2004-02-06
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SOLUTION, TABLET, TABLET, EXTENDED RELEASE
Companies
LANNETT CO INC ANI PHARMS RHODES PHARMS NUVO PHARM NESHER PHARMS Dr. Reddy's GENUS LIFESCIENCES ALVOGEN EPIC PHARMA LLC ASCENT PHARMS INC AVANTHI INC NOVEL LABS INC PHARM ASSOC Teva Sun Pharma SPECGX LLC ALKEM LABS LTD IMPAX LABS IMPAX PHARMS STRIDES PHARMA INTL Hikma AMNEAL PHARMS HIBROW HLTHCARE QUAGEN VISTAPHARM LLC AUROLIFE PHARMA LLC CHARTWELL MOLECULAR ABHAI LLC MALLINCKRODT PHARMOBEDIENT
Active Ingredient: OXYCODONE HYDROCHLORIDE
Website: ↗
OXYCODONE HYDROCHLORIDE Approval History
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What OXYCODONE HYDROCHLORIDE Treats
47 FDA approvalsOriginally approved for its first indication in 2004 . Covers 47 distinct patient populations.
- Other (47)
Other
(47 approvals)- • Approved indication (Feb 2004)Letter
- • Approved indication (Jun 2004)
- • Approved indication (Dec 2005)
- • Approved indication (Jan 2007)
- • Approved indication (Jul 2008)
- • Approved indication (Apr 2009)Letter
- • Approved indication (Aug 2009)Letter
- • Approved indication (Aug 2009)
- • Approved indication (Oct 2010)Label Letter
- • Approved indication (Feb 2011)
- • Approved indication (Mar 2011)
- • Approved indication (Dec 2011)
- • Approved indication (Jan 2012)Label Letter
- • Approved indication (Jul 2012)
- • Approved indication (Jul 2012)
- • Approved indication (Nov 2012)
- • Approved indication (Jul 2013)
- • Approved indication (Jul 2013)
- • Approved indication (Jun 2014)
- • Approved indication (Jun 2014)
- • Approved indication (Aug 2014)Letter
- • Approved indication (Sep 2014)Letter
- • Approved indication (Apr 2015)
- • Approved indication (Jun 2015)Letter
- • Approved indication (Jun 2015)Letter
- • Approved indication (Aug 2015)
- • Approved indication (Aug 2015)
- • Approved indication (Sep 2015)Label Letter
- • Approved indication (Mar 2016)Letter
- • Approved indication (Apr 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Jun 2017)Letter
- • Approved indication (Jul 2017)Letter
- • Approved indication (Aug 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Aug 2017)Letter
- • Approved indication (Aug 2017)
- • Approved indication (Sep 2017)Letter
- • Approved indication (Nov 2017)Letter
- • Approved indication (Apr 2018)
- • Approved indication (Feb 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Apr 2020)
- • Approved indication (Jun 2021)
- • Approved indication (Jul 2021)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.
OXYCODONE 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.