Details for New Drug Application (NDA): 209017
✉ Email this page to a colleague
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 209017
Tradename: | POLYETHYLENE GLYCOL 3350 |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | polyethylene glycol 3350 |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209017
Mechanism of Action | Osmotic Activity |
Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion |
Suppliers and Packaging for NDA: 209017
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
POLYETHYLENE GLYCOL 3350 | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 209017 | ANDA | Aurohealth LLC | 58602-805 | 58602-805-01 | 119 g in 1 BOTTLE, PLASTIC (58602-805-01) |
POLYETHYLENE GLYCOL 3350 | polyethylene glycol 3350 | FOR SOLUTION;ORAL | 209017 | ANDA | Aurohealth LLC | 58602-805 | 58602-805-02 | 238 g in 1 BOTTLE, PLASTIC (58602-805-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | FOR SOLUTION;ORAL | Strength | 17GM/SCOOPFUL | ||||
Approval Date: | Apr 9, 2018 | TE: | RLD: | No |
Complete Access Available with Subscription