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Drug Product Composition: 05433_FLUKA

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USFDA APPLICATION NUMBER - 19797 / DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
polyethylene glycol 3350(UNII: G2M7P15E5P)
(polyethylene glycol 3350 - UNII:G2M7P15E5P)
polyethylene glycol 3350420g in 4
potassium chloride(UNII: 660YQ98I10)
(chloride ion - UNII:Q32ZN48698)
potassium chloride1.48g in 4
sodium bicarbonate(UNII: 8MDF5V39QO)
(bicarbonate ion - UNII:HN1ZRA3Q20)
sodium bicarbonate5.72g in 4
sodium chloride(UNII: 451W47IQ8X)
(chloride ion - UNII:Q32ZN48698)
sodium chloride11.2g in 4

Inactive Ingredients

Ingredient Name
Strides Pharma Science Limited
Braintree Laboratories, Inc.
Lupin Pharmaceuticals,Inc.
ACESULFAME POTASSIUM(23OV73Q5G9)  
CHERRY(BUC5I9595W)  
LEMON(24RS0A988O) 
LIME (CITRUS)(8CZS546954) 
MALTODEXTRIN(7CVR7L4A2D)  
ORANGE(5EVU04N5QU) 
PINEAPPLE(2A88ZO081O)  
SACCHARIN SODIUM(SB8ZUX40TY)