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 |
|---|---|---|---|---|---|
2019/01/31 | Phase 3 | Completed | Children's Cancer Hospital Egypt 57357 | ||
2019/01/31 | Phase 3 | UNKNOWN | Dr M. B. Breebaart | ||
2019/01/30 | Phase 3 | Recruiting | |||
2019/01/18 | Phase 4 | Completed | |||
2018/12/26 | Not Applicable | UNKNOWN | |||
2018/12/13 | Phase 3 | Active, not recruiting | |||
2018/10/31 | Phase 4 | Completed | |||
2018/10/23 | Not Applicable | Recruiting | |||
2018/10/19 | Phase 4 | Completed | |||
2018/10/09 | Phase 4 | Completed | The Institute of Molecular and Translational Medicine, Czech Republic |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lake Erie Medical DBA Quality Care Products LLC | 55700-368 | ORAL | 60 mg in 1 1 | 10/29/2019 | |
| Dispensing Solutions, Inc. | 66336-502 | ORAL | 30 mg in 1 1 | 4/8/2013 | |
| Lake Erie Medical DBA Quality Care Products LLC | 35356-836 | ORAL | 15 mg in 1 1 | 10/29/2019 | |
| American Health Packaging | 68084-157 | ORAL | 15 mg in 1 1 | 8/24/2022 | |
| PAI Holdings, LLC | 0121-4955 | ORAL | 10 mg in 5 mL | 9/15/2025 | |
| PAI Holdings, LLC dba PAI Pharma | 0121-4955 | ORAL | 10 mg in 5 mL | 9/15/2025 | |
| Winder Laboratories LLC | 75826-130 | ORAL | 20 mg in 5 mL | 2/28/2022 | |
| STAT Rx USA LLC | 16590-966 | ORAL | 15 mg in 1 1 | 5/31/2012 | |
| Hospira, Inc. | 0409-2022 | INTRAVENOUS | 50 mg in 1 mL | 12/28/2023 | |
| Fresenius Kabi USA, LLC | 76045-007 | INTRAVENOUS, INTRAMUSCULAR | 8 mg in 1 mL | 8/31/2020 |
EMA Drug Approvals
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|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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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 |
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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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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| No Malaysia NPRA approvals found for this drug. | |||||
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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