Application Nr Approved Date Route Status External Links
ANDA205386 2016-10-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Morphine Sulfate Extended-Release Tablets Are Indicated For The Management Of Pain Severe Enough To Require Daily, Around-The-Clock, Long-Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. Morphine Sulfate Extended-Release Tablets Are An Opioid Agonist Indicated For The Management Of Pain Severe Enough To Require Daily, Around-The-Clock, Long-Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. (1) Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, And Because Of The Greater Risks Of Overdose And Death With Extended-Release Opioid Formulations, Reserve Morphine Sulfate Extended-Release Tablets For Use In Patients For Whom Alternative Treatment Options (e.g., Non-Opioid Analgesics Or Immediate-Release Opioids) Are Ineffective, Not Tolerated, Or Would Be Otherwise Inadequate To Provide Sufficient Management Of Pain. (1) Morphine Sulfate Extended-Release Tablets Are Not Indicated As An As-Needed (prn) Analgesic. (1) Limitations Of Use Because Of The Risks Of Addiction, Abuse, And Misuse With Opioids, Even At Recommended Doses, And Because Of The Greater Risks Of Overdose And Death With Extended-Release Opioid Formulations [see Warnings And Precautions (5.1)], Reserve Morphine Sulfate Extended-Release Tablets For Use In Patients For Whom Alternative Treatment Options (e.g., Non- Opioid Analgesics Or Immediate-Release Opioids) Are Ineffective, Not Tolerated, Or Would Be Otherwise Inadequate To Provide Sufficient Management Of Pain. Morphine Sulfate Extended-Release Tablets Are Not Indicated As An As-Needed (prn) Analgesic.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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