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Setid 84ef0ae0 1eca 44cc 9528 37c6a1521e55 Applno 21539 Form Injectable Intravenous Dosage 6gm 30ml 200mg Ml - Drug Product Composition: Acetylcysteinum

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USFDA APPLICATION NUMBER - 21539 / DOSAGE - INJECTABLE;INTRAVENOUS - 6GM/30ML (200MG/ML)

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETYLCYSTEINE(UNII: WYQ7N0BPYC)
(ACETYLCYSTEINE - UNII:WYQ7N0BPYC)
ACETYLCYSTEINE200mg in 1

Inactive Ingredients

Ingredient Name
Eugia US LLC
Exela Pharma Sciences, LLC
Indoco Remedies Limited
Sagent Pharmaceuticals
Zydus Pharmaceuticals USA Inc.
Cumberland Pharmaceuticals Inc.
Padagis US LLC
Paddock Laboratories, LLC
edetate disodium(7FLD91C86K)   
nitrogen(N762921K75)      
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)