Application Nr Approved Date Route Status External Links
ANDA201011 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Morphine Sulfate Oral Solution (10 Mg Per 5 Ml And 20 Mg Per 5 Ml) Are Formulations Of Morphine, An Opioid Agonist, Indicated For The Relief Of Moderate To Severe Acute And Chronic Pain Where Use Of An Opioid Analgesic Is Appropriate. Morphine Sulfate Oral Solution 100 Mg Per 5 Ml (20 Mg/ml) Is An Opioid Analgesic Indicated For The Relief Of Moderate To Severe Acute And Chronic Pain In Opioid-Tolerant Patients. Morphine Sulfate Oral Solution 100 Mg Per 5 Ml (20 Mg/ml) May Cause Fatal Respiratory Depression When Administered To Patients Not Previously Exposed To Opioids. Patients Considered To Be Opioid Tolerant Are Those Who Are Taking At Least 60 Mg Oral Morphine Per Day, Or At Least 30 Mg Of Oral Oxycodone Per Day, Or At Least 12 Mg Hydromorphone Per Day, Or An Equianalgesic Dose Of Another Opioid, For A Week Or Longer. Morphine Sulfate Is An Opioid Agonist Indicated For The Relief Of Moderate To Severe Acute And Chronic Pain Where An Opioid Analgesic Is Appropriate. ( 1 ) Morphine Sulfate 100 Mg Per 5 Ml (20 Mg/ml) Solution Is Indicated For The Relief Of Moderate To Severe Acute And Chronic Pain In Opioid-Tolerant Patients. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Morphine Sulfate MORPHINE SULFATE ZINC3812983

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