Overview
Oxycodone is a semisynthetic opioid analgesic derived from thebaine in Germany in 1917. It is currently indicated as an immediate release product for moderate to severe pain and as an extended release product for chronic moderate to severe pain requiring continuous opioid analgesics for an extended period. The first oxycodone containing product, Percodan, was approved by the FDA on April 12, 1950.
Indication
Oxycodone is indicated for the treatment of moderate to severe pain. There is also an extended release formulation indicated for chronic moderate to severe pain requiring continuous opioid analgesics for an extended period.
Associated Conditions
- Severe Acute Pain
- Severe Pain
- Severe, Chronic Pain
- Acute, moderate Pain
- Chronic, moderate Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/31 | Not Applicable | Not yet recruiting | |||
2025/04/08 | Not Applicable | Not yet recruiting | |||
2025/03/07 | Phase 4 | Completed | |||
2025/01/03 | Phase 1 | Recruiting | Shanna Babalonis, PhD | ||
2024/12/09 | Not Applicable | Not yet recruiting | Ailin Luo | ||
2024/11/01 | Phase 4 | Active, not recruiting | University of Tennessee Graduate School of Medicine | ||
2024/10/30 | Not Applicable | Not yet recruiting | Shantou University Medical College | ||
2024/10/07 | Phase 2 | Completed | |||
2024/09/19 | Phase 3 | Not yet recruiting | |||
2024/08/06 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Granules Pharmaceuticals Inc. | 70010-670 | ORAL | 10 mg in 1 1 | 3/7/2024 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1560 | ORAL | 40 mg in 1 1 | 3/19/2019 | |
| Bryant Ranch Prepack | 63629-2104 | ORAL | 5 mg in 5 mL | 1/5/2022 | |
| STAT RX USA LLC | 16590-659 | ORAL | 15 mg in 1 1 | 8/26/2010 | |
| Camber Pharmaceuticals, Inc. | 31722-193 | ORAL | 7.5 mg in 1 1 | 4/13/2017 | |
| Bryant Ranch Prepack | 71335-1421 | ORAL | 5 mg in 1 1 | 2/10/2022 | |
| SpecGx LLC | 0406-0552 | ORAL | 5 mg in 1 1 | 1/25/2023 | |
| KVK-TECH,INC | 10702-008 | ORAL | 15 mg in 1 1 | 11/10/2023 | |
| Quality Care Products, LLC | 35356-801 | ORAL | 10 mg in 1 1 | 12/23/2022 | |
| Physicians Total Care, Inc. | 54868-2094 | ORAL | 4.5 mg in 1 1 | 8/29/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| OXYCODONE KALCEKS SOLUTION FOR INJECTION OR INFUSION 10 MG/ML | SIN16635P | INJECTION, SOLUTION | 10.0mg/ml | 11/4/2022 | |
| OXYNORM 5MG CAPSULE | SIN13083P | CAPSULE | 5mg | 4/7/2005 | |
| OXYCONTIN® NEO CONTROLLED-RELEASE TABLET 10 mg | SIN14884P | TABLET, FILM COATED, EXTENDED RELEASE | 10.0 mg | 10/28/2015 | |
| OxyNorm® Sterile Solution for Injection or Infusion 10mg/ml | SIN13733P | INJECTION, SOLUTION | 9 mg/ml | 11/18/2009 | |
| OXYCODONE WOCKHARDT SOLUTION FOR INJECTION OR INFUSION 10MG/ML | SIN15996P | INJECTION, SOLUTION | 10.00 mg/mL | 8/21/2020 | |
| OXYCONTIN® NEO CONTROLLED-RELEASE TABLETS 20 MG | SIN14885P | TABLET, FILM COATED, EXTENDED RELEASE | 20 mg | 10/28/2015 | |
| OXYCONTIN 10mg prolonged release tablets | SIN13077P | TABLET, FILM COATED, EXTENDED RELEASE | 10mg | 4/7/2005 | |
| OXYNORM 10MG CAPSULE | SIN13079P | CAPSULE | 10 mg | 4/7/2005 | |
| OXYNORM® Oral Solution 1mg/ml | SIN14125P | SOLUTION | 1mg per ml | 3/28/2012 | |
| OXYCONTIN® NEO CONTROLLED-RELEASE TABLETS 40 MG | SIN14886P | TABLET, FILM COATED, EXTENDED RELEASE | 40 mg | 10/28/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| OXYCONTIN PROLONGED RELEASE TAB 5MG | N/A | N/A | N/A | 5/13/2010 | |
| OXYNORM CAP 10MG | N/A | N/A | N/A | 5/13/2010 | |
| PMS-OXYCODONE HYDROCHLORIDE TABLETS 5MG | N/A | N/A | N/A | 1/8/2019 | |
| OXYCODONE HYDROCHLORIDE SANDOZ PROLONGED-RELEASE TABLETS 20MG | N/A | N/A | N/A | 7/28/2021 | |
| OXYCONTIN PROLONGED RELEASE TAB 20 MG | N/A | N/A | N/A | 5/13/2010 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ENDOCET | bristol-myers squibb canada | 01916548 | Tablet - Oral | 5 MG | 12/31/1995 |
| OXYCONTIN 20MG | purdue pharma | 02202468 | Tablet (Extended-Release) - Oral | 20 MG | 12/31/1996 |
| APO-OXYCODONE CR | 02306530 | Tablet (Extended-Release) - Oral | 40 MG | 11/26/2012 | |
| SUPEUDOL 10 | 00392480 | Suppository - Rectal | 10 MG | 12/31/1973 | |
| PMS-OXYCODONE CR | 02309912 | Tablet (Extended-Release) - Oral | 80 MG | 11/27/2012 | |
| NU-OXYCODONE/ACET | nu-pharm inc | 02336391 | Tablet - Oral | 5 MG | N/A |
| OXYCONTIN 5MG | purdue pharma | 02258129 | Tablet (Extended-Release) - Oral | 5 MG | 4/1/2005 |
| OXYCONTIN | purdue pharma | 02323206 | Tablet (Extended-Release) - Oral | 30 MG | 5/1/2009 |
| PERCODAN-DEMI | bristol-myers squibb canada | 01916556 | Tablet - Oral | 2.5 MG | 12/31/1993 |
| TEVA-OXYCODONE CR | teva canada limited | 02291266 | Tablet (Extended-Release) - Oral | 40 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OXYNORM 10 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION | Mundipharma Pharmaceuticals S.L. | 71243 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Medicamento Sujeto A Prescripción Médica. Estupefacientes | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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