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Drug Product Composition: AMINO ACIDS

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USFDA APPLICATION NUMBER - 200656 / DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALANINE (UNII: OF5P57N2ZX)
(ALANINE - UNII:OF5P57N2ZX)
ALANINE 333mg in 100
ARGININE (UNII: 94ZLA3W45F)
(ARGININE - UNII:94ZLA3W45F)
ARGININE 235mg in 100
ASPARTIC ACID (UNII: 30KYC7MIAI)
(ASPARTIC ACID - UNII:30KYC7MIAI)
ASPARTIC ACID 71mg in 100
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
(CHLORIDE ION - UNII:Q32ZN48698)
CALCIUM CHLORIDE 20mg in 100
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
(ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
DEXTROSE MONOHYDRATE 7.5g in 100
GLUTAMIC ACID (UNII: 3KX376GY7L)
(GLUTAMIC ACID - UNII:3KX376GY7L)
GLUTAMIC ACID 116mg in 100
GLYCINE (UNII: TE7660XO1C)
(GLYCINE - UNII:TE7660XO1C)
GLYCINE 164mg in 100
HISTIDINE (UNII: 4QD397987E)
(HISTIDINE - UNII:4QD397987E)
HISTIDINE 141mg in 100
ISOLEUCINE (UNII: 04Y7590D77)
(ISOLEUCINE - UNII:04Y7590D77)
ISOLEUCINE 116mg in 100
LEUCINE (UNII: GMW67QNF9C)
(LEUCINE - UNII:GMW67QNF9C)
LEUCINE 164mg in 100
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
(LYSINE - UNII:K3Z4F929H6)
LYSINE187mg in 100
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
(MAGNESIUM CATION - UNII:T6V3LHY838)
MAGNESIUM SULFATE HEPTAHYDRATE 68mg in 100
METHIONINE (UNII: AE28F7PNPL)
(METHIONINE - UNII:AE28F7PNPL)
METHIONINE 116mg in 100
PHENYLALANINE (UNII: 47E5O17Y3R)
(PHENYLALANINE - UNII:47E5O17Y3R)
PHENYLALANINE 164mg in 100
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
(CHLORIDE ION - UNII:Q32ZN48698)
POTASSIUM CHLORIDE 124mg in 100
PROLINE (UNII: 9DLQ4CIU6V)
(PROLINE - UNII:9DLQ4CIU6V)
PROLINE 141mg in 100
SERINE (UNII: 452VLY9402)
(SERINE - UNII:452VLY9402)
SERINE 94mg in 100
SODIUM ACETATE (UNII: 4550K0SC9B)
(ACETATE ION - UNII:569DQM74SC)
ACETATE ION170mg in 100
SODIUM GLYCEROPHOSPHATE ANHYDROUS (UNII: YP1H63LJ2K)
(PHOSPHATE ION - UNII:NK08V8K8HR)
SODIUM GLYCEROPHOSPHATE ANHYDROUS 105mg in 100
SOYBEAN OIL (UNII: 241ATL177A)
(SOYBEAN OIL - UNII:241ATL177A)
SOYBEAN OIL 3.5g in 100
THREONINE (UNII: 2ZD004190S)
(THREONINE - UNII:2ZD004190S)
THREONINE 116mg in 100
TRYPTOPHAN (UNII: 8DUH1N11BX)
(TRYPTOPHAN - UNII:8DUH1N11BX)
TRYPTOPHAN 40mg in 100
TYROSINE (UNII: 42HK56048U)
(TYROSINE - UNII:42HK56048U)
TYROSINE 4.8mg in 100
VALINE (UNII: HG18B9YRS7)
(VALINE - UNII:HG18B9YRS7)
VALINE 152mg in 100

Inactive Ingredients

Ingredient Name
Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC
ACETIC ACID(Q40Q9N063P)
EGG PHOSPHOLIPIDS(1Z74184RGV)
GLYCERIN(PDC6A3C0OX)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)