63323-712-10 |
63323-712 |
HUMAN PRESCRIPTION DRUG |
Kabiven |
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine |
INJECTION, EMULSION |
INTRAVENOUS |
20140825 |
N/A |
NDA |
NDA200656 |
Fresenius Kabi USA, LLC |
ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
467 mg/100mL; 330 mg/100mL; 99 mg/100mL; 29 mg/100mL; 10.8 g/100mL; 164 mg/100mL; 231 mg/100mL; 199 mg/100mL; 164 mg/100mL; 231 mg/100mL; 263 mg/100mL; 96 mg/100mL; 164 mg/100mL; 231 mg/100mL; 174 mg/100mL; 199 mg/100mL; 131 mg/100mL; 239 mg/100mL; 147 mg/100mL; 3.9 g/100mL; 164 mg/100mL; 55 mg/100mL; 6.7 mg/100mL; 213 mg/100mL |
1026 mL in 1 BAG (63323-712-10) |
63323-712-15 |
63323-712 |
HUMAN PRESCRIPTION DRUG |
Kabiven |
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine |
INJECTION, EMULSION |
INTRAVENOUS |
20140825 |
N/A |
NDA |
NDA200656 |
Fresenius Kabi USA, LLC |
ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
467 mg/100mL; 330 mg/100mL; 99 mg/100mL; 29 mg/100mL; 10.8 g/100mL; 164 mg/100mL; 231 mg/100mL; 199 mg/100mL; 164 mg/100mL; 231 mg/100mL; 263 mg/100mL; 96 mg/100mL; 164 mg/100mL; 231 mg/100mL; 174 mg/100mL; 199 mg/100mL; 131 mg/100mL; 239 mg/100mL; 147 mg/100mL; 3.9 g/100mL; 164 mg/100mL; 55 mg/100mL; 6.7 mg/100mL; 213 mg/100mL |
1540 mL in 1 BAG (63323-712-15) |
63323-712-20 |
63323-712 |
HUMAN PRESCRIPTION DRUG |
Kabiven |
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine |
INJECTION, EMULSION |
INTRAVENOUS |
20140825 |
N/A |
NDA |
NDA200656 |
Fresenius Kabi USA, LLC |
ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
467 mg/100mL; 330 mg/100mL; 99 mg/100mL; 29 mg/100mL; 10.8 g/100mL; 164 mg/100mL; 231 mg/100mL; 199 mg/100mL; 164 mg/100mL; 231 mg/100mL; 263 mg/100mL; 96 mg/100mL; 164 mg/100mL; 231 mg/100mL; 174 mg/100mL; 199 mg/100mL; 131 mg/100mL; 239 mg/100mL; 147 mg/100mL; 3.9 g/100mL; 164 mg/100mL; 55 mg/100mL; 6.7 mg/100mL; 213 mg/100mL |
2053 mL in 1 BAG (63323-712-20) |
63323-712-25 |
63323-712 |
HUMAN PRESCRIPTION DRUG |
Kabiven |
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine |
INJECTION, EMULSION |
INTRAVENOUS |
20140825 |
N/A |
NDA |
NDA200656 |
Fresenius Kabi USA, LLC |
ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
467 mg/100mL; 330 mg/100mL; 99 mg/100mL; 29 mg/100mL; 10.8 g/100mL; 164 mg/100mL; 231 mg/100mL; 199 mg/100mL; 164 mg/100mL; 231 mg/100mL; 263 mg/100mL; 96 mg/100mL; 164 mg/100mL; 231 mg/100mL; 174 mg/100mL; 199 mg/100mL; 131 mg/100mL; 239 mg/100mL; 147 mg/100mL; 3.9 g/100mL; 164 mg/100mL; 55 mg/100mL; 6.7 mg/100mL; 213 mg/100mL |
2566 mL in 1 BAG (63323-712-25) |
63323-714-14 |
63323-714 |
HUMAN PRESCRIPTION DRUG |
Perikabiven |
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine |
INJECTION, EMULSION |
INTRAVENOUS |
20140825 |
N/A |
NDA |
NDA200656 |
Fresenius Kabi USA, LLC |
ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
333 mg/100mL; 235 mg/100mL; 71 mg/100mL; 20 mg/100mL; 7.5 g/100mL; 116 mg/100mL; 164 mg/100mL; 141 mg/100mL; 116 mg/100mL; 164 mg/100mL; 187 mg/100mL; 68 mg/100mL; 116 mg/100mL; 164 mg/100mL; 124 mg/100mL; 141 mg/100mL; 94 mg/100mL; 170 mg/100mL; 105 mg/100mL; 3.5 g/100mL; 116 mg/100mL; 40 mg/100mL; 4.8 mg/100mL; 152 mg/100mL |
1440 mL in 1 BAG (63323-714-14) |
63323-714-19 |
63323-714 |
HUMAN PRESCRIPTION DRUG |
Perikabiven |
Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine |
INJECTION, EMULSION |
INTRAVENOUS |
20140825 |
N/A |
NDA |
NDA200656 |
Fresenius Kabi USA, LLC |
ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
333 mg/100mL; 235 mg/100mL; 71 mg/100mL; 20 mg/100mL; 7.5 g/100mL; 116 mg/100mL; 164 mg/100mL; 141 mg/100mL; 116 mg/100mL; 164 mg/100mL; 187 mg/100mL; 68 mg/100mL; 116 mg/100mL; 164 mg/100mL; 124 mg/100mL; 141 mg/100mL; 94 mg/100mL; 170 mg/100mL; 105 mg/100mL; 3.5 g/100mL; 116 mg/100mL; 40 mg/100mL; 4.8 mg/100mL; 152 mg/100mL |
1920 mL in 1 BAG (63323-714-19) |