NDA 207648

FRESENIUS KABI USA

FDA Drug Application

Application #207648

Documents

• Letter: 2016-07-14
• Label: 2016-07-28
• Review: 2018-01-12
• Letter: 2020-05-11
• Label: 2020-05-12
• Label: 2022-03-23
• Letter: 2022-03-23

Application Sponsors

NDA 207648

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	EMULSION;INTRAVENOUS	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)	1	SMOFLIPID 20%	FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
002	EMULSION;INTRAVENOUS	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)	1	SMOFLIPID 20%	FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
003	EMULSION;INTRAVENOUS	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)	1	SMOFLIPID 20%	FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL
004	EMULSION;INTRAVENOUS	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)	1	SMOFLIPID 20%	FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2016-07-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-05-08	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2022-03-22	PRIORITY

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	5	Null	7

CDER Filings

FRESENIUS KABI USA

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(
    [0] => Array
        (
            [ApplNo] => 207648
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SMOFLIPID 20%","activeIngredients":"FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL","strength":"3GM\/100ML;6GM\/100ML;5GM\/100ML;6GM\/100ML (100ML)","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SMOFLIPID 20%","activeIngredients":"FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL","strength":"3GM\/100ML;6GM\/100ML;5GM\/100ML;6GM\/100ML (250ML)","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SMOFLIPID 20%","activeIngredients":"FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL","strength":"3GM\/100ML;6GM\/100ML;5GM\/100ML;6GM\/100ML (500ML)","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SMOFLIPID 20%","activeIngredients":"FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL","strength":"3GM\/100ML;6GM\/100ML;5GM\/100ML;6GM\/100ML (1000ML)","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/08\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207648s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207648lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/13\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207648lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207648Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/207648Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/08\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207648s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [actionDate] => 2020-05-08
        )

)