DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 076491
NDA 076491 describes TRILYTE, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the TRILYTE profile page.
The generic ingredient in TRILYTE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are four hundred and nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.
The generic ingredient in TRILYTE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are four hundred and nineteen drug master file entries for this compound. Eight 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 Pharms Inc |
| Ingredient: | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076491
| Ingredient-type | Potassium Compounds |
| 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 | N | 51525-6831-4 |
| TRILYTE | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride | FOR SOLUTION;ORAL | 076491 | ANDA | Alaven Pharmaceutical LLC | 68220-131 | E | 68220-131-04 |
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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