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    Drug Product Composition: Benzathine Benzylpenicillin

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    Benzathine Benzylpenicillin

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

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    USFDA APPLICATION NUMBER - 50138 / DOSAGE - INJECTABLE;INJECTION - 300,000 UNITS/ML;300,000 UNITS/ML

    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PENICILLIN G BENZATHINE(UNII: RIT82F58GK)
    (PENICILLIN G - UNII:Q42T66VG0C)     		PENICILLIN G90000[iU] in 2
    PENICILLIN G PROCAINE(UNII: 17R794ESYN)
    (PENICILLIN G - UNII:Q42T66VG0C)     		PENICILLIN G30000[iU] in 2

    Inactive Ingredients

    Ingredient Name
    Pfizer Laboratories Div Pfizer Inc
    CARBOXYMETHYLCELLULOSE(05JZI7B19X)
    LECITHIN, SOYBEAN(1DI56QDM62)
    METHYLPARABEN(A2I8C7HI9T)
    POVIDONE, UNSPECIFIED(FZ989GH94E)
    PROPYLPARABEN(Z8IX2SC1OH)
    SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
    WATER(059QF0KO0R)