Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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NDC API
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VMF
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Australia
US Medicaid
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Annual Reports
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FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40168
Submission : 2024-07-04
Status : Active
Type : II

Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2016-03-04
Registration Number : Su4238-2-ND
Manufacturer Name : Fresenius Kabi Deutschland GmbH
Manufacturer Address : Werk Friedberg Pfingstweide 53, D-61169 Friedberg, Germany

Registrant Name : Kemport Co., Ltd.
Registration Date : 2015-12-08
Registration Number : 3-1-ND
Manufacturer Name : Kemport Co., Ltd.
Manufacturer Address : (58275) 30-51 Dongsu Agricultural and Industrial Complex Road, Naju-si, Jeollanam-do

Registrant Name : WiseMedi Co., Ltd.
Registration Date : 2014-10-15
Registration Number : Su4786-1-ND(2)
Manufacturer Name : Lipoid GmbH
Manufacturer Address : Frigenstrasse 4, D-67065 Ludwigshafen, Federal Republic of Germany

Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2006-03-02
Registration Number : Su-31-ND
Manufacturer Name : Fresenius Kabi AB
Manufacturer Address : Rapsgatan 7 SE-751 74 Uppsala SWEDEN

Registrant Name : JW Life Science Co., Ltd.
Registration Date : 2013-09-27
Registration Number : Su4786-1-ND
Manufacturer Name : Lipoid GmbH
Manufacturer Address : Frigenstrasse 4, D-67065 Ludwigshafen, Federal Republic of Germany

Registrant Name : HK Innoen Co., Ltd.
Registration Date : 2014-05-13
Registration Number : Su4786-1-ND(1)
Manufacturer Name : Lipoid GmbH
Manufacturer Address : Frigenstrasse 4, D-67065 Ludwigshafen, Federal Republic of Germany

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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Carena
Dosage Form : Ointment
Dosage Strength : 5MG; 270 MG
Packaging :
Approval Date : 01-12-1960
Application Number : 35090
Regulatory Info : Cancelled
Registration Country : Spain
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Regulatory Info : Generic
Registration Country : Bahrain
Brand Name : Feom-3
Dosage Form : CAPSULE
Dosage Strength : 1000MG; 1IU
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Bahrain

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Regulatory Info : Generic
Registration Country : Bahrain
Brand Name : Olifix
Dosage Form : CAPSULE
Dosage Strength : 1000MG
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Bahrain

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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info : RX
Registration Country : USA
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)
Packaging :
Approval Date : 2016-07-13
Application Number : 207648
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
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)
Packaging :
Approval Date : 2016-07-13
Application Number : 207648
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
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)
Packaging :
Approval Date : 2016-07-13
Application Number : 207648
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
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)
Packaging :
Approval Date : 2018-08-10
Application Number : 207648
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : OMEGAVEN
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 5GM/50ML (0.1GM/ML)
Packaging :
Approval Date : 2018-07-27
Application Number : 210589
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : OMEGAVEN
Dosage Form : EMULSION;INTRAVENOUS
Dosage Strength : 10GM/100ML (0.1GM/ML)
Packaging :
Approval Date : 2018-07-27
Application Number : 210589
Regulatory Info : RX
Registration Country : USA

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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 :

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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 :

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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 :

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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 :

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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 :

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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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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