Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210589

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OMEGAVEN (FISH OIL TRIGLYCERIDES)
5GM/50ML (0.1GM/ML)
Marketing Status: Prescription

Active Ingredient: FISH OIL TRIGLYCERIDES
Proprietary Name: OMEGAVEN
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 5GM/50ML (0.1GM/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210589
Product Number: 001
Approval Date: Jul 27, 2018
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

OMEGAVEN (FISH OIL TRIGLYCERIDES)
10GM/100ML (0.1GM/ML)
Marketing Status: Prescription

Active Ingredient: FISH OIL TRIGLYCERIDES
Proprietary Name: OMEGAVEN
Dosage Form; Route of Administration: EMULSION; INTRAVENOUS
Strength: 10GM/100ML (0.1GM/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210589
Product Number: 002
Approval Date: Jul 27, 2018
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information