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Drug Product Composition: AMINO ACIDS

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USFDA APPLICATION NUMBER - 19018 / DOSAGE - INJECTABLE;INJECTION - 6% (6GM/100ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYL L-TYROSINE(UNII: DA8G610ZO5)
(ACETYL L-TYROSINE - UNII:DA8G610ZO5)
ACETYL L-TYROSINE0.24g in 100 | 0.12g in 100
ALANINE(UNII: OF5P57N2ZX)
(ALANINE - UNII:OF5P57N2ZX)
ALANINE0.54g in 100 | 0.32g in 100
ARGININE(UNII: 94ZLA3W45F)
(ARGININE - UNII:94ZLA3W45F)
ARGININE1.2g in 100 | 0.73g in 100
ASPARTIC ACID(UNII: 30KYC7MIAI)
(ASPARTIC ACID - UNII:30KYC7MIAI)
ASPARTIC ACID0.32g in 100 | 0.19g in 100
CYSTEINE HYDROCHLORIDE(UNII: ZT934N0X4W)
(CYSTEINE - UNII:K848JZ4886)
CYSTEINE0.024g in 100 | 0.020g in 100
GLUTAMIC ACID(UNII: 3KX376GY7L)
(GLUTAMIC ACID - UNII:3KX376GY7L)
GLUTAMIC ACID0.5g in 100 | 0.3g in 100
GLYCINE(UNII: TE7660XO1C)
(GLYCINE - UNII:TE7660XO1C)
GLYCINE0.36g in 100 | 0.22g in 100
HISTIDINE(UNII: 4QD397987E)
(HISTIDINE - UNII:4QD397987E)
HISTIDINE0.48g in 100 | 0.29g in 100
ISOLEUCINE(UNII: 04Y7590D77)
(ISOLEUCINE - UNII:04Y7590D77)
ISOLEUCINE0.82g in 100 | 0.49g in 100
LEUCINE(UNII: GMW67QNF9C)
(LEUCINE - UNII:GMW67QNF9C)
LEUCINE1.4g in 100 | 0.84g in 100
LYSINE ACETATE(UNII: TTL6G7LIWZ)
(LYSINE - UNII:K3Z4F929H6)
LYSINE1.2g in 100 | 0.69g in 100
METHIONINE(UNII: AE28F7PNPL)
(METHIONINE - UNII:AE28F7PNPL)
METHIONINE0.34g in 100 | 0.2g in 100
PHENYLALANINE(UNII: 47E5O17Y3R)
(PHENYLALANINE - UNII:47E5O17Y3R)
PHENYLALANINE0.48g in 100 | 0.29g in 100
PROLINE(UNII: 9DLQ4CIU6V)
(PROLINE - UNII:9DLQ4CIU6V)
PROLINE0.68g in 100 | 0.41g in 100
SERINE(UNII: 452VLY9402)
(SERINE - UNII:452VLY9402)
SERINE0.38g in 100 | 0.23g in 100
TAURINE(UNII: 1EQV5MLY3D)
(TAURINE - UNII:1EQV5MLY3D)
TAURINE0.025g in 100 | 0.015g in 100
THREONINE(UNII: 2ZD004190S)
(THREONINE - UNII:2ZD004190S)
THREONINE0.42g in 100 | 0.25g in 100
TRYPTOPHAN(UNII: 8DUH1N11BX)
(TRYPTOPHAN - UNII:8DUH1N11BX)
TRYPTOPHAN0.2g in 100 | 0.12g in 100
TYROSINE(UNII: 42HK56048U)
(TYROSINE - UNII:42HK56048U)
TYROSINE0.044g in 100 | 0.044g in 100
VALINE(UNII: HG18B9YRS7)
(VALINE - UNII:HG18B9YRS7)
VALINE0.78g in 100 | 0.47g in 100

Inactive Ingredients

Ingredient Name
B. Braun Medical Inc.
ACETIC ACID(Q40Q9N063P)
SODIUM METABISULFITE(4VON5FNS3C)
WATER(059QF0KO0R)