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Drug Product Composition: Gadolinium Dtpa

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USFDA APPLICATION NUMBER - 21037 / DOSAGE - INJECTABLE;INJECTION - 469.01MG/ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GADOPENTETATE DIMEGLUMINE(UNII: RH248G8V27)
(GADOPENTETATE - UNII:V7OK6J19HQ)
GADOPENTETATE DIMEGLUMINE469.0mg in 1

Inactive Ingredients

Ingredient Name
Alvogen, Inc
Bayer HealthCare Pharmaceuticals Inc.
MEGLUMINE(6HG8UB2MUY)
PENTETIC ACID(7A314HQM0I)
WATER(059QF0KO0R)