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Generated: October 23, 2018

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Details for New Drug Application (NDA): 090186

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NDA 090186 describes PEG 3350 AND ELECTROLYTES, which is a drug marketed by Mylan and Novel Labs Inc and is included in three NDAs. It is available from three suppliers. Additional details are available on the PEG 3350 AND ELECTROLYTES profile page.

The generic ingredient in PEG 3350 AND ELECTROLYTES is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. 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; sodium sulfate anhydrous profile page.
Suppliers and Packaging for NDA: 090186
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PEG 3350 AND ELECTROLYTES polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 090186 ANDA Novel Laboratories, Inc. 40032-060 40032-060-19 278.26 g in 1 BOTTLE (40032-060-19)
PEG 3350 AND ELECTROLYTES polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 090186 ANDA Lupin Pharmaceuticals,Inc. 43386-060 43386-060-19 278.26 g in 1 BOTTLE (43386-060-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
Approval Date:Jun 1, 2009TE:AARLD:No

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