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Drug Product Composition: Gadoversetamide

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USFDA APPLICATION NUMBER - 20937 / DOSAGE - INJECTABLE;INJECTION - 1654.5MG/5ML (330.9MG/ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GADOVERSETAMIDE(UNII: RLM74T3Z9D)
(GADOLINIUM CATION (3+) - UNII:AZV954TZ9N)
GADOVERSETAMIDE0.5mmol in 1

Inactive Ingredients

Ingredient Name
Liebel-Flarsheim Company LLC
CALCIUM CHLORIDE(M4I0D6VV5M)
CALCIUM VERSETAMIDE SODIUM(T8281IVO8L)
HYDROCHLORIC ACID(QTT17582CB)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)