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01 6FRESENIUS KABI USA

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PharmaCompass

01

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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 :

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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 :

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03

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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 :

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04

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

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 :

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05

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

FISH OIL TRIGLYCERIDES

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 :

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06

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

FISH OIL TRIGLYCERIDES

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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