63323-820-00 |
63323-820 |
HUMAN PRESCRIPTION DRUG |
Smoflipid |
Smoflipid |
INJECTION, EMULSION |
INTRAVENOUS |
20160713 |
N/A |
NDA |
NDA207648 |
Fresenius Kabi USA, LLC |
FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
3 g/100mL; 6 g/100mL; 5 g/100mL; 6 g/100mL |
10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01) |
63323-820-10 |
63323-820 |
HUMAN PRESCRIPTION DRUG |
Smoflipid |
Smoflipid |
INJECTION, EMULSION |
INTRAVENOUS |
20190527 |
N/A |
NDA |
NDA207648 |
Fresenius Kabi USA, LLC |
FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
3 g/100mL; 6 g/100mL; 5 g/100mL; 6 g/100mL |
6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05) |
63323-820-12 |
63323-820 |
HUMAN PRESCRIPTION DRUG |
Smoflipid |
Smoflipid |
INJECTION, EMULSION |
INTRAVENOUS |
20160713 |
N/A |
NDA |
NDA207648 |
Fresenius Kabi USA, LLC |
FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
3 g/100mL; 6 g/100mL; 5 g/100mL; 6 g/100mL |
20 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02) |
63323-820-50 |
63323-820 |
HUMAN PRESCRIPTION DRUG |
Smoflipid |
Smoflipid |
INJECTION, EMULSION |
INTRAVENOUS |
20160713 |
N/A |
NDA |
NDA207648 |
Fresenius Kabi USA, LLC |
FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
3 g/100mL; 6 g/100mL; 5 g/100mL; 6 g/100mL |
12 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03) |
63323-820-74 |
63323-820 |
HUMAN PRESCRIPTION DRUG |
Smoflipid |
Smoflipid |
INJECTION, EMULSION |
INTRAVENOUS |
20160713 |
N/A |
NDA |
NDA207648 |
Fresenius Kabi USA, LLC |
FISH OIL; MEDIUM-CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
3 g/100mL; 6 g/100mL; 5 g/100mL; 6 g/100mL |
10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04) |