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Serving leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
McKesson
Federal Trade Commission
Covington
Chubb
Dow
Harvard Business School
Novartis
Johnson and Johnson

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207648

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NDA 207648 describes SMOFLIPID 20%, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. Additional details are available on the SMOFLIPID 20% profile page.

The generic ingredient in SMOFLIPID 20% is fish oil; medium chain triglycerides; olive oil; soybean oil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fish oil; medium chain triglycerides; olive oil; soybean oil profile page.

Summary for 207648

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 207648

Ingredient-typeLipids

Suppliers and Packaging for NDA: 207648

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820 63323-820-74 100 mL in 1 BAG (63323-820-74)
SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820 63323-820-50 100 mL in 1 BAG (63323-820-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:EMULSION;INTRAVENOUSStrength3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)
Approval Date:Jul 13, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 13, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:EMULSION;INTRAVENOUSStrength3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)
Approval Date:Jul 13, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 13, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:EMULSION;INTRAVENOUSStrength3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)
Approval Date:Jul 13, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 13, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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Serving leading biopharmaceutical companies globally:

Medtronic
Cantor Fitzgerald
Express Scripts
QuintilesIMS
Argus Health
Johnson and Johnson
Cerilliant
Citi
Healthtrust
Julphar

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