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Drug Product Composition: Exenatide Synthetic

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USFDA APPLICATION NUMBER - 21773 / DOSAGE - INJECTABLE;SUBCUTANEOUS - 300MCG/1.2ML (250MCG/ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
exenatide(UNII: 9P1872D4OL)
(exenatide - UNII:9P1872D4OL)
exenatide250ug in 1 | 250ug in 1

Inactive Ingredients

Ingredient Name
Amylin Pharmaceuticals, LLC
AstraZeneca Pharmaceuticals LP
acetic acid(Q40Q9N063P)
mannitol(3OWL53L36A)
metacresol(GGO4Y809LO)
sodium acetate(4550K0SC9B)
water(059QF0KO0R)