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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 NDA: 207648

Tradename:
SMOFLIPID 20%
Applicant:
Fresenius Kabi Usa
Ingredient:
fish oil; medium chain triglycerides; olive oil; soybean oil
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 63323-820-00 100 mL in 1 BAG (63323-820-00)
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

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

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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