Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207648

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SMOFLIPID 20% (FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL)
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)
Marketing Status: Prescription

Active Ingredient: FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Proprietary Name: SMOFLIPID 20%
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207648
Product Number: 002
Approval Date: Jul 13, 2016
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SMOFLIPID 20% (FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL)
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)
Marketing Status: Prescription

Active Ingredient: FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Proprietary Name: SMOFLIPID 20%
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207648
Product Number: 003
Approval Date: Jul 13, 2016
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SMOFLIPID 20% (FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL)
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)
Marketing Status: Prescription

Active Ingredient: FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Proprietary Name: SMOFLIPID 20%
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207648
Product Number: 001
Approval Date: Jul 13, 2016
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SMOFLIPID 20% (FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL)
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)
Marketing Status: Prescription

Active Ingredient: FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Proprietary Name: SMOFLIPID 20%
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207648
Product Number: 004
Approval Date: Aug 10, 2018
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information