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.
Background
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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/09/08 | Phase 3 | Completed | |||
2016/07/06 | Phase 1 | Active, not recruiting | |||
2016/04/18 | Phase 4 | Terminated | |||
2016/04/15 | Phase 3 | Terminated | |||
2016/04/05 | Phase 4 | Completed | |||
2016/03/23 | Phase 3 | Completed | |||
2016/01/21 | Phase 4 | Completed | |||
2015/12/09 | Not Applicable | Completed | |||
2015/11/13 | Phase 3 | Completed | |||
2015/11/13 | Phase 3 | Completed | St. Olavs Hospital |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 72162-1336 | ORAL | 15 mg in 1 1 | 3/16/2021 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0826 | ORAL | 100 mg in 5 mL | 4/19/2021 | |
| Redpharm Drug, Inc | 67296-1855 | ORAL | 5 mg in 1 1 | 11/28/2023 | |
| Major Pharmaceuticals | 0904-7180 | ORAL | 15 mg in 1 1 | 2/8/2022 | |
| Redpharm Drug, Inc | 67296-1855 | ORAL | 5 mg in 1 1 | 3/9/2023 | |
| Bryant Ranch Prepack | 71335-1414 | ORAL | 30 mg in 1 1 | 2/10/2022 | |
| Amneal Pharmaceuticals of New York LLC | 0115-1556 | ORAL | 10 mg in 1 1 | 3/19/2019 | |
| DIRECT RX | 61919-659 | ORAL | 15 mg in 1 1 | 1/21/2020 | |
| Bryant Ranch Prepack | 71335-1023 | ORAL | 20 mg in 1 1 | 12/22/2021 | |
| Direct_Rx | 72189-357 | ORAL | 5 mg in 1 1 | 7/5/2023 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CHEMMART OXYCODONE MR oxycodone hydrochloride 10mg modified release tablets blister pack | 214498 | Medicine | A | 11/21/2014 | |
| OXYCONTIN oxycodone hydrochloride 30mg modified release tablet blister pack | 200025 | Medicine | A | 10/22/2013 | |
| CHEMMART OXYCODONE MR oxycodone hydrochloride 40mg tablet blister pack | 160095 | Medicine | A | 11/11/2010 | |
| XEDONE oxycodone hydrochloride 20mg capsule bottle | 227859 | Medicine | A | 11/18/2015 | |
| OXYCODONE-WGR oxycodone hydrochloride 5mg film coated tablet blister pack | 297750 | Medicine | A | 5/29/2019 |