Application Nr Approved Date Route Status External Links
NDA207648 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Smoflipid Is Indicated In Adults As A Source Of Calories And Essential Fatty Acids For Parenteral Nutrition When Oral Or Enteral Nutrition Is Not Possible, Insufficient, Or Contraindicated. Smoflipid Is Indicated In Adults As A Source Of Calories And Essential Fatty Acids For Parenteral Nutrition When Oral Or Enteral Nutrition Is Not Possible, Insufficient, Or Contraindicated.( 1 ) Limitations Of Use The Omega-6: Omega-3 Fatty Acid Ratio And Medium Chain Triglycerides In Smoflipid Have Not Been Shown To Improve Clinical Outcomes Compared To Other Intravenous Lipid Emulsions. ( 1 ) Limitations Of Use The Omega-6: Omega-3 Fatty Acid Ratio And Medium Chain Triglycerides In Smoflipid Have Not Been Shown To Improve Clinical Outcomes Compared To Other Intravenous Lipid Emulsions [See Clinical Studies ( 14 )].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 4 Total)

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