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 |
|---|---|---|---|---|---|
2025/04/08 | 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 | |||
2024/08/02 | Not Applicable | Not yet recruiting | Jianbo Wu |
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 |
|---|---|---|---|---|---|
| Oxycodone Hydrochloride Tablets | 国药准字H20090214 | 化学药品 | 片剂 | 5/16/2024 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字H20247091 | 化学药品 | 片剂 | 4/30/2024 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字HJ20140312 | 化学药品 | 片剂 | 2/6/2024 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字HJ20140320 | 化学药品 | 片剂 | 2/6/2024 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字HJ20140314 | 化学药品 | 片剂 | 2/6/2024 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字HJ20140313 | 化学药品 | 片剂 | 2/6/2024 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字HJ20170052 | 化学药品 | 片剂 | 2/6/2024 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字HJ20210052 | 化学药品 | 片剂 | 6/30/2021 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字HJ20140324 | 化学药品 | 片剂 | 2/6/2024 | |
| Oxycodone Hydrochloride Prolonged-release Tablets | 国药准字HJ20140317 | 化学药品 | 片剂 | 2/6/2024 |
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
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