Application Nr Approved Date Route Status External Links
ANDA204393 None Intrathecal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Mitigo Is For Use In Continuous Microinfusion Devices And Indicated Only For Intrathecal Or Epidural Infusion In The Management Of Intractable Chronic Pain Severe Enough To Require An Opioid Analgesic And For Which Less Invasive Means Of Controlling Pain Are Inadequate. Limitations Of Use Not For Single-Dose Intravenous, Intramuscular, Or Subcutaneous Administration Due To The Risk Of Overdose. Not For Single-Dose Neuraxial Injection Because Mitigo Is Too Concentrated For Accurate Delivery Of The Smaller Doses Used In This Setting. Mitigo (Morphine Sulfate Injection, Usp – Preservative-Free) Is An Opioid Agonist, For Use In Continuous Microinfusion Devices And Indicated Only For Intrathecal Or Epidural Infusion In The Management Of Intractable Chronic Pain Severe Enough To Require An Opioid Analgesic And For Which Alternative Treatments Are Inadequate. ( 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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