MedPath

Morphine

Generic Name
Morphine
Brand Names
Arymo, Avinza, Doloral, Duramorph, Embeda, Infumorph, Kadian, M-ediat, M-eslon, MSIR, Mitigo, Ms Contin, Statex
Drug Type
Small Molecule
Chemical Formula
C17H19NO3
CAS Number
57-27-2
Unique Ingredient Identifier
76I7G6D29C

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
2023/09/01
Phase 4
Completed
Universiti Kebangsaan Malaysia Medical Centre
2023/08/24
Phase 4
Completed
National University of Malaysia
2023/07/27
Not Applicable
Completed
2023/06/27
Phase 4
Recruiting
University Hospital Ostrava
2023/06/22
Phase 3
Active, not recruiting
2023/06/15
Phase 4
Recruiting
Pouya Azar
2023/05/30
Not Applicable
Recruiting
2023/05/10
Not Applicable
Completed
2023/05/08
Phase 4
Not yet recruiting
Qianfoshan Hospital
2023/04/06
Phase 2
Recruiting
Instituto Nacional de Cancer, Brazil

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sun Pharmaceutical Industries, Inc.
63304-453
ORAL
200 mg in 1 1
12/14/2023
Mayne Pharma Commercial LLC
51862-188
ORAL
100 mg in 1 1
7/6/2023
Zydus Pharmaceuticals (USA) Inc.
68382-907
ORAL
200 mg in 1 1
12/17/2021
Mayne Pharma Commercial LLC
51862-187
ORAL
60 mg in 1 1
7/6/2023
Winder Laboratories LLC
75826-129
ORAL
10 mg in 5 mL
2/28/2022
RedPharm Drug, Inc.
67296-1753
ORAL
15 mg in 1 1
1/21/2022
Purdue Pharma LP
59011-260
ORAL
15 mg in 1 1
3/23/2017
SpecGx LLC
0406-5118
ORAL
15 mg in 1 1
3/21/2024
Mayne Pharma Commercial LLC
51862-615
ORAL
15 mg in 1 1
7/5/2023
Cantrell Drug Company
52533-161
INTRAVENOUS, INTRAMUSCULAR, INTRATHECAL, EPIDURAL
2 mg in 1 mL
5/1/2014

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
M.O.S.-60 TAB 60MG
valeant canada lp / valeant canada s.e.c.
00690244
Tablet - Oral
60 MG
12/31/1986
MS CONTIN SUPPOSITORIES - 100MG
purdue pharma
02145952
Suppository (Sustained-Release) - Rectal
100 MG / SUP
12/31/1995
NTP-MORPHINE SR
teva canada limited
02346389
Tablet (Extended-Release) - Oral
60 MG
N/A
MS CONTIN XL CAPSULES
purdue pharma
02242828
Capsule (Sustained-Release) - Oral
60 MG / SRC
N/A
MS.IR
purdue pharma
02014211
Tablet (Immediate Release) - Oral
10 MG
12/31/1993
MORPHINE SULFATE INJECTION, USP
fresenius kabi canada ltd
02482703
Solution - Subcutaneous ,  Intravenous ,  Intramuscular
4 MG / 1 ML
N/A
STATEX
Endo Operations Ltd.
00594652
Tablet - Oral
5 MG
12/31/1985
PMS-MORPHINE SULFATE SR 15 MG
02245284
Tablet (Extended-Release) - Oral
15 MG
2/20/2002
PMS-MORPHINE SULFATE
02549816
Tablet - Oral
25 MG
N/A
MORPHINE SULPHATE INJECTION,USP LIQ 1.1MG/ML
International Medication Systems Ltd.
02010364
Liquid - Intravenous ,  Refer (See Dosage Form)
1.1 MG / ML
12/31/1993

CIMA AEMPS Drug Approvals

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Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Company
Registration Number
Dosage Form
Strength
Approval Date
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
No UK EMC drug information found for this drug.

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