Details for New Drug Application (NDA): 019011
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NDA 019011 describes GOLYTELY, which is a drug marketed by Braintree and is included in one NDA. It is available from three suppliers. Additional details are available on the GOLYTELY profile page.
The generic ingredient in GOLYTELY 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.
The generic ingredient in GOLYTELY 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 019011
| Tradename: | GOLYTELY |
| Applicant: | Braintree |
| Ingredient: | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous |
| Patents: | 0 |
Pharmacology for NDA: 019011
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion |
Suppliers and Packaging for NDA: 019011
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GOLYTELY | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | FOR SOLUTION;ORAL | 019011 | NDA AUTHORIZED GENERIC | Affordable Pharmaceuticals, LLC | 10572-100 | 10572-100-01 | 4 L in 1 JUG (10572-100-01) |
| GOLYTELY | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | FOR SOLUTION;ORAL | 019011 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-6521 | 50090-6521-0 | 4 L in 1 JUG (50090-6521-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT | ||||
| Approval Date: | Jul 13, 1984 | TE: | AA | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | ||||
| Approval Date: | Jun 2, 1992 | TE: | RLD: | Yes | |||||
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