01 6FRESENIUS KABI USA
01 6EMULSION;INTRAVENOUS
01 6RX
01 2OMEGAVEN
02 4SMOFLIPID 20%
01 6Yes
RLD : Yes
TE Code :
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Brand Name : SMOFLIPID 20%
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)
Approval Date : 2016-07-13
Application Number : 207648
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Brand Name : SMOFLIPID 20%
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)
Approval Date : 2016-07-13
Application Number : 207648
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Brand Name : SMOFLIPID 20%
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)
Approval Date : 2016-07-13
Application Number : 207648
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
Brand Name : SMOFLIPID 20%
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)
Approval Date : 2018-08-10
Application Number : 207648
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OMEGAVEN
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 5GM/50ML (0.1GM/ML)
Approval Date : 2018-07-27
Application Number : 210589
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OMEGAVEN
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 10GM/100ML (0.1GM/ML)
Approval Date : 2018-07-27
Application Number : 210589
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
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