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Details for New Drug Application (NDA): 076491
The generic ingredient in TRILYTE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are four hundred and twenty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.
Summary for 076491
Tradename: | TRILYTE |
Applicant: | Mylan |
Ingredient: | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride |
Patents: | 0 |
Pharmacology for NDA: 076491
Mechanism of Action | Osmotic Activity |
Physiological Effect | Stimulation Large Intestine Fluid/Electrolyte Secretion Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 076491
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRILYTE | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride | FOR SOLUTION;ORAL | 076491 | ANDA | Wallace Pharmaceuticals Inc. | 51525-6831 | 51525-6831-4 | 4 L in 1 BOTTLE (51525-6831-4) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | ||||
Approval Date: | Feb 5, 2004 | TE: | AA | RLD: | No |
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