Data updated: Jun 28, 2026
OXYCODONE HYDROCHLORIDE
Pain
Approved 1998-10-26
47
Indications
--
Phase 3 Trials
27
Years on Market
Details
- Status
- Prescription
- First Approved
- 1998-10-26
- Routes
- ORAL
- Dosage Forms
- SOLUTION, TABLET, TABLET, EXTENDED RELEASE, CAPSULE
Companies
GENUS LIFESCIENCES VISTAPHARM LLC AUROLIFE PHARMA LLC EPIC PHARMA LLC CHARTWELL MOLECULAR PHARM ASSOC Teva ANI PHARMS NESHER PHARMS LANNETT CO INC Hikma PHARMOBEDIENT SPECGX LLC ALKEM LABS LTD IMPAX PHARMS NOVEL LABS INC ASCENT PHARMS INC STRIDES PHARMA INTL Sun Pharma RHODES PHARMS Dr. Reddy's HIBROW HLTHCARE IMPAX LABS QUAGEN MALLINCKRODT ALVOGEN AMNEAL PHARMS NUVO PHARM ABHAI LLC AVANTHI INC
Active Ingredient: OXYCODONE HYDROCHLORIDE
Website: ↗
OXYCODONE HYDROCHLORIDE Approval History
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
689 FDA actions from 2004 to 2026 · 1 indication expansions
Jan 2026 SUPPL
Label · Labeling
Dec 2025 SUPPL
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Oct 2021 SUPPL
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Jun 2021 ORIGINAL
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Jun 2004 ORIGINAL
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Jun 2004 SUPPL
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May 2004 SUPPL
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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
📋
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02536209 | MT-8554-E03 | Ph 1 | completed | A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects |
| NCT04240626 | 1452523 | Ph 4 | active not recruiting | Multimodal Analgesia Effect on Post Surgical Patient |
| NCT03685188 | WCH2018086 | Ph 4 | enrolling by invitation | Oxycodone and Sufentanil for Analgesia in Hip Surgery |
| NCT06444997 | B2024-161R | Ph 4 | not yet recruiting | Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients |
| NCT02531906 | I 262314 NCI-2015-01338, I 262314 | Ph 1 | completed | Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation |
| NCT03586934 | ORA 17071004 | Ph 3 | withdrawn | Multimodal Analgesia in Shoulder Arthroplasty |
| NCT01643772 results posted | OXYC09-CN-102 | Ph 1 | completed | OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study |
| NCT02660229 SWITCH results posted | OXI15-KR-401 | Ph 4 | completed | An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion. |
| NCT03254459 results posted | INS005-17-111 | Ph 2 | completed | Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain |
| NCT00626600 | OXI3001 2007-005101-21 | Ph 3 | terminated | A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion |
| NCT00801788 | OC-EG-001 | Ph 1 | completed | Single Dose Pharmacokinetics of Egalet® Oxycodone |
| NCT01530542 | K234-10-1001 B4501006 | Ph 1 | completed | A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers |
🔬
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.