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Details for New Drug Application (NDA): 076491
NDA 076491 describes TRILYTE, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. 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 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.
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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