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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 two 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 fourteen drug master file entries for this compound. Eight 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.

Pharmacology for NDA: 090186

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 GAVIS Pharmaceuticals, LLC 43386-060 43386-060-19 278.26 g in 1 BOTTLE (43386-060-19)

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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