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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 090409


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NDA 090409 describes PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, which is a drug marketed by Nostrum Labs Inc, Novel Labs Inc, Rising, and Strides Pharma, and is included in four NDAs. It is available from two suppliers. Additional details are available on the PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE profile page.

The generic ingredient in PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are four hundred and twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Approval Date:Apr 2, 2010TE:RLD:No

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