Overview
Morphine, the main alkaloid of opium, was first obtained from poppy seeds in 1805. It is a potent analgesic, though its use is limited due to tolerance, withdrawal, and the risk of abuse. Morphine is still routinely used today, though there are a number of semi-synthetic opioids of varying strength such as codeine, fentanyl, methadone, hydrocodone, hydromorphone, meperidine, and oxycodone. Morphine was granted FDA approval in 1941.
Indication
Morphine is used for the management of chronic, moderate to severe pain. Opiods, including morphine, are effective for the short term management of pain. Patients taking opioids long term may need to be monitored for the development of physical dependence, addiction disorder, and drug abuse.
Associated Conditions
- Chronic Pain
- Severe Pain
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/04/13 | Phase 3 | Withdrawn | |||
2022/04/12 | Phase 3 | Recruiting | |||
2022/04/04 | Phase 4 | Completed | Kresimir Oremus, MD | ||
2022/02/22 | Phase 1 | Withdrawn | Lyndra Inc. | ||
2022/02/11 | Phase 3 | Completed | University Hospital, Akershus | ||
2022/01/26 | Not Applicable | Completed | |||
2022/01/11 | Phase 2 | UNKNOWN | |||
2021/12/09 | Early Phase 1 | Completed | |||
2021/12/03 | Phase 1 | Recruiting | |||
2021/11/30 | Phase 3 | Completed | Oslo University Hospital |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-6557 | ORAL | 15 mg in 1 1 | 1/3/2019 | |
| SpecGx LLC | 0406-8320 | ORAL | 200 mg in 1 1 | 1/30/2023 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-1170 | ORAL | 10 mg in 5 mL | 1/18/2021 | |
| Fresenius Kabi, USA LLC | 76045-008 | INTRAVENOUS, INTRAMUSCULAR | 10 mg in 1 mL | 8/10/2018 | |
| Bryant Ranch Prepack | 71335-0676 | ORAL | 30 mg in 1 1 | 10/31/2019 | |
| Tris Pharma Inc | 27808-082 | ORAL | 20 mg in 1 mL | 7/31/2022 | |
| SpecGx LLC | 0406-8003 | ORAL | 20 mg in 1 mL | 1/30/2023 | |
| Mayne Pharma Commercial LLC | 51862-617 | ORAL | 30 mg in 1 1 | 7/5/2023 | |
| Bryant Ranch Prepack | 72162-1791 | ORAL | 100 mg in 1 1 | 9/8/2023 | |
| STAT RX USA LLC | 16590-885 | ORAL | 200 mg in 1 1 | 6/15/2011 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MORPHINE SULFATE INJECTION USP | ICU Medical Canada Inc | 00649619 | Solution - Intravenous | 5 MG / ML | 12/31/1986 |
| MS.IR | purdue pharma | 02014238 | Tablet (Immediate Release) - Oral | 20 MG | 12/31/1991 |
| MORPHINE SULFATE INJECTION BP | Sterimax Inc | 02474980 | Solution - Intravenous
,
Subcutaneous
,
Intramuscular | 10 MG / ML | 9/21/2018 |
| M.O.S. SULPHATE 50MG TAB | valeant canada lp / valeant canada s.e.c. | 02009706 | Tablet - Oral | 50 MG | 12/31/1993 |
| M.O.S.-20 TAB 20MG | valeant canada lp / valeant canada s.e.c. | 00690201 | Tablet - Oral | 20 MG | 12/31/1986 |
| M.O.S. SYRUP 5MG/ML | valeant canada lp / valeant canada s.e.c. | 00514217 | Syrup - Oral | 5 MG / ML | 12/31/1981 |
| SANDOZ MORPHINE SR | 02244792 | Tablet (Extended-Release) - Oral | 60 MG | 11/14/2001 | |
| ZOMORPH | 02254190 | Capsule (Sustained-Release) - Oral | 40 MG | N/A | |
| STATEX DROPS 20MG/ML | paladin pharma inc. | 00621935 | Drops - Oral | 20 MG / ML | 12/31/1984 |
| M-EDIAT | 02320398 | Capsule (Immediate Release) - Oral | 5 MG | 9/6/2016 |
CIMA AEMPS Drug Approvals
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|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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