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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207648
Company: FRESENIUS KABI USA

Products on NDA 207648

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SMOFLIPID 20%	FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes
SMOFLIPID 20%	FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes
SMOFLIPID 20%	FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes
SMOFLIPID 20%	FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL	3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)	EMULSION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207648

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/2016	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207648lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207648Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207648Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207648s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207648Orig1s010ltr.pdf
03/22/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207648s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207648Orig1s005ltr.pdf
05/08/2020	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207648s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207648Orig1s003, 210589Orig1s001ltr.pdf

Labels for NDA 207648

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207648s010lbl.pdf
03/22/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207648s005lbl.pdf
05/08/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207648s003lbl.pdf
07/13/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207648lbl.pdf

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