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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 fourteen drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the polyethylene glycol 3350 profile page.

Summary for NDA: 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 11523-4357 11523-4357-1 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (11523-4357-1) > 765 g in 1 BOTTLE, PLASTIC
MIRALAX
polyethylene glycol 3350
FOR SOLUTION;ORAL 022015 NDA Bayer HealthCare 11523-4357 11523-4357-3 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (11523-4357-3) > 578 g in 1 BOTTLE, PLASTIC

Summary for product number 001

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


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