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    Setid 1d88fbe0 Eb97 4964 8a78 88940064f8f0 Applno 19018 Form Injectable Injection Dosage 6 6gm 100ml - Drug Product Composition: PERIKABIVEN IN PLASTIC CONTAINER

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    PERIKABIVEN IN PLASTIC CONTAINER

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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)