FDA.reportPublic FDA data

Application 207648

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)YesYes
002SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)YesYes
003SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)YesYes
004SMOFLIPID 20%FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OILEMULSION;INTRAVENOUS3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent
63323-820SmoflipidSmoflipidFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82946SUPPL 2025-07-28
82929SUPPL 2025-07-25
74296SUPPL 2023-05-18
74277SUPPL 2023-05-18
70586SUPPL2022-03-23
70584SUPPL2022-03-23
62931SUPPL2020-05-12
62898SUPPL2020-05-11
51045ORIG2018-01-12
40591ORIG2016-07-28
10621ORIG2016-07-14