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Generated: September 26, 2018

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Details for New Drug Application (NDA): 204559

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NDA 204559 describes PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, which is a drug marketed by Mylan, Novel Labs Inc, Strides Pharma, and Breckenridge Pharm, and is included in four NDAs. It is available from three 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 drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.
Suppliers and Packaging for NDA: 204559
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION;ORAL 204559 ANDA Strides Shasun Limited 64380-768 64380-768-21 4 L in 1 JUG (64380-768-21)
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION;ORAL 204559 ANDA Strides Shasun Limited 64380-769 64380-769-21 4 L in 1 JUG (64380-769-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Approval Date:Apr 13, 2015TE:AARLD:No

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