SMOFLIPID 20% |
207648 |
001 |
NDA |
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) |
Yes
|
Yes
|
2016/07/13
|
2016/07/13
|
FRESENIUS KABI USA |
Prescription |
SMOFLIPID 20% |
207648 |
002 |
NDA |
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) |
Yes
|
Yes
|
2016/07/13
|
2016/07/13
|
FRESENIUS KABI USA |
Prescription |
SMOFLIPID 20% |
207648 |
003 |
NDA |
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) |
Yes
|
Yes
|
2016/07/13
|
2016/07/13
|
FRESENIUS KABI USA |
Prescription |
SMOFLIPID 20% |
207648 |
004 |
NDA |
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) |
Yes
|
Yes
|
2016/07/13
|
2018/08/10
|
FRESENIUS KABI USA |
Prescription |