PERIKABIVEN IN PLASTIC CONTAINER |
200656 |
001 |
NDA |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML) |
Yes
|
No
|
2014/08/25
|
2014/08/25
|
FRESENIUS KABI USA |
Prescription |
PERIKABIVEN IN PLASTIC CONTAINER |
200656 |
002 |
NDA |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML) |
Yes
|
No
|
2014/08/25
|
2014/08/25
|
FRESENIUS KABI USA |
Prescription |
PERIKABIVEN IN PLASTIC CONTAINER |
200656 |
003 |
NDA |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML) |
Yes
|
Yes
|
2014/08/25
|
2014/08/25
|
FRESENIUS KABI USA |
Prescription |
KABIVEN IN PLASTIC CONTAINER |
200656 |
004 |
NDA |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML) |
Yes
|
No
|
2014/08/25
|
2014/08/25
|
FRESENIUS KABI USA |
Prescription |
KABIVEN IN PLASTIC CONTAINER |
200656 |
005 |
NDA |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML) |
Yes
|
No
|
2014/08/25
|
2014/08/25
|
FRESENIUS KABI USA |
Prescription |
KABIVEN IN PLASTIC CONTAINER |
200656 |
006 |
NDA |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML) |
Yes
|
No
|
2014/08/25
|
2014/08/25
|
FRESENIUS KABI USA |
Prescription |
KABIVEN IN PLASTIC CONTAINER |
200656 |
007 |
NDA |
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL |
EMULSION;INTRAVENOUS |
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML) |
Yes
|
Yes
|
2014/08/25
|
2014/08/25
|
FRESENIUS KABI USA |
Prescription |