Application Nr Approved Date Route Status External Links
NDA204508 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Clinolipid Is Indicated In Adults For Providing A Source Of Calories And Essential Fatty Acids For Parenteral Nutrition When Oral Or Enteral Nutrition Is Not Possible, Insufficient, Or Contraindicated. Limitations Of Use Clinolipid Is Not Indicated For Use In Pediatric Patients Because There Is Insufficient Data To Demonstrate That Clinolipid Provides Sufficient Amounts Of Essential Fatty Acids In This Population. [see Use In Specific Populations (8.4) ] The Omega-3: Omega-6 Fatty Acid Ratio In Clinolipid Has Not Been Shown To Improve Clinical Outcomes Compared To Other Intravenous Lipid Emulsions. [see Clinical Studies (14) ] Clinolipid Is Indicated In Adults For Parenteral Nutrition Providing A Source Of Calories And Essential Fatty Acids When Oral Or Enteral Nutrition Is Not Possible, Insufficient, Or Contraindicated. ( 1 ) Limitations Of Use: • Clinolipid Is Not Indicated For Use In Pediatric Patients Because There Is Insufficient Data To Demonstrate That Clinolipid Provides Sufficient Amounts Of Essential Fatty Acids In This Population ( 1 , 8.4 ) • The Omega-3: Omega-6 Fatty Acid Ratio In Clinolipid Has Not Been Shown To Improve Clinical Outcomes Compared To Other Intravenous Lipid Emulsions ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Olive Oil
2. Soybean Oil

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