NDA 210589

FRESENIUS KABI USA

FDA Drug Application

Application #210589

Documents

• Label: 2018-07-27
• Letter: 2018-07-30
• Review: 2018-08-24
• Letter: 2020-05-11
• Label: 2020-05-12

Application Sponsors

NDA 210589

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	EMULSION;INTRAVENOUS	5GM/50ML (0.1GM/ML)	1	OMEGAVEN	FISH OIL TRIGLYCERIDES
002	EMULSION;INTRAVENOUS	10GM/100ML (0.1GM/ML)	1	OMEGAVEN	FISH OIL TRIGLYCERIDES

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination

ORIG

1

AP

2018-07-27

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

FRESENIUS KABI USA

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(
    [0] => Array
        (
            [ApplNo] => 210589
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMEGAVEN","activeIngredients":"FISH OIL TRIGLYCERIDES","strength":"5GM\/50ML (0.1GM\/ML)","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OMEGAVEN","activeIngredients":"FISH OIL TRIGLYCERIDES","strength":"10GM\/100ML (0.1GM\/ML)","dosageForm":"EMULSION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/08\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210589s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/0210589s000lbledt.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/27\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/0210589s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210589Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210589Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/08\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210589s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [actionDate] => 2020-05-08
        )

)