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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022015


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NDA 022015 describes MIRALAX, which is a drug marketed by Bayer Healthcare Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the MIRALAX profile page.

The generic ingredient in MIRALAX is polyethylene glycol 3350. There are four hundred and twenty-one drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350 profile page.
Summary for 022015
Tradename:MIRALAX
Applicant:Bayer Healthcare Llc
Ingredient:polyethylene glycol 3350
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022015
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRALAX polyethylene glycol 3350 FOR SOLUTION;ORAL 022015 NDA Bayer HealthCare LLC. 11523-4357 11523-4357-2 2 CARTON in 1 CARTON (11523-4357-2) > 20 PACKET in 1 CARTON > 17 g in 1 PACKET
MIRALAX polyethylene glycol 3350 FOR SOLUTION;ORAL 022015 NDA Bayer HealthCare LLC. 11523-4357 11523-4357-3 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (11523-4357-3) > 578 g in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 022015
Tradename Dosage Ingredient NDA Submissiondate
MIRALAX FOR SOLUTION;ORAL polyethylene glycol 3350 022015

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:FOR SOLUTION;ORALStrength17GM/SCOOPFUL
Approval Date:Oct 6, 2006TE:RLD:Yes

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