Application Nr Approved Date Route Status External Links
ANDA202348 2011-07-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Morphine Sulfate Oral Solution Is Indicated For The Management Of Acute And Chronic Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. Morphine Sulfate Oral Solution 100 Mg Per 5 Ml (20 Mg/ml) Is Indicated For The Relief Of Acute And Chronic Pain In Opioid-Tolerant Patients. Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses [see Warnings And Precautions (5.2)], Reserve Morphine Sulfate Oral Solution For Use In Patients For Whom Alternative Treatment Options [e.g., Non-Opioid Analgesics Or Opioid Combination Products]: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia Morphine Sulfate Oral Solution Is An Opioid Agonist Indicated For The Management Of Acute And Chronic Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. (1) Limitations Of Use (1) Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, Reserve Morphine Sulfate Oral Solution For Use In Patients For Whom Alternative Treatment Options [e.g., Non-Opioid Analgesics Or Opioid Combination Products]: Have Not Been Tolerated, Or Are Not Expected To Be Tolerated, Have Not Provided Adequate Analgesia, Or Are Not Expected To Provide Adequate Analgesia

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
2. Edetate Disodium EDETATE DISODIUM Molecular

Active Ingredients ( 1 Total)

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

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