Details for New Drug Application (NDA): 090812
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The generic ingredient in POLYETHYLENE GLYCOL 3350 is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. There are four hundred and twenty-one drug master file entries for this compound. Six 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.
Summary for 090812
Tradename: | POLYETHYLENE GLYCOL 3350 |
Applicant: | Lgm Pharma |
Ingredient: | polyethylene glycol 3350 |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090812
Mechanism of Action | Osmotic Activity |
Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Suppliers and Packaging for NDA: 090812
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POLYETHYLENE GLYCOL 3350 | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 090812 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0962 | 17856-0962-1 | 72 POUCH in 1 BOX, UNIT-DOSE (17856-0962-1) / 4 g in 1 POUCH |
POLYETHYLENE GLYCOL 3350 | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 090812 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0962 | 17856-0962-2 | 72 POUCH in 1 BOX, UNIT-DOSE (17856-0962-2) / 4.25 g in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/SCOOPFUL | ||||
Approval Date: | Oct 7, 2009 | TE: | RLD: | No |
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