Application Nr Approved Date Route Status External Links
ANDA079040 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Morphine Sulfate Extended-Release Capsules 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. 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 Capsules 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 Capsules Are Not Indicated As An As-Needed (Prn) Analgesic. Morphine Sulfate Extended-Release Capsules 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 Capsules 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 Capsules Are Not Indicated As An As-Needed (Prn) Analgesic. ( 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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