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Generated: September 21, 2018

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Details for New Drug Application (NDA): 019011

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NDA 019011 describes GOLYTELY, which is a drug marketed by Braintree and is included in one NDA. It is available from two suppliers. Additional details are available on the GOLYTELY profile page.

The generic ingredient in GOLYTELY 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: 019011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GOLYTELY polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 019011 NDA AUTHORIZED GENERIC Affordable Pharmaceuticals, LLC 10572-100 10572-100-01 4 L in 1 JUG (10572-100-01)
GOLYTELY polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 019011 NDA AUTHORIZED GENERIC Affordable Pharmaceuticals, LLC 10572-101 10572-101-01 4 L in 1 JUG (10572-101-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
Approval Date:Jul 13, 1984TE:AARLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET
Approval Date:Jun 2, 1992TE:RLD:Yes

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