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 four 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-three suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350 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-three 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 |
Pharmacology for NDA: 022015
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/SCOOPFUL | ||||
| Approval Date: | Oct 6, 2006 | TE: | RLD: | Yes | |||||
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