Overview
A narcotic analgesic that may be habit-forming. It is nearly as effective orally as by injection.
Background
A narcotic analgesic that may be habit-forming. It is nearly as effective orally as by injection.
Indication
For the management of moderate to severe pain or as a preoperative medication where an opioid analgesic is appropriate.
Associated Conditions
- Severe Pain
- Moderate Pain
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/07/06 | Early Phase 1 | Active, not recruiting | |||
2006/01/11 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bryant Ranch Prepack | 63629-2093 | ORAL | 2 mg in 1 1 | 8/14/2021 | |
| SpecGx LLC | 0406-2224 | ORAL | 2 mg in 1 1 | 6/28/2023 | |
| Virtus Pharmaceuticals, LLC | 69543-417 | ORAL | 2 mg in 1 1 | 9/1/2020 | |
| Sun Pharmaceutical Industries, Inc. | 57664-762 | ORAL | 2 mg in 1 1 | 6/29/2021 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||