Details for New Drug Application (NDA): 204558
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NDA 204558 describes POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, which is a drug marketed by Paddock Llc and Strides Pharma and is included in two NDAs. It is available from one supplier. Additional details are available on the POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES profile page.
The generic ingredient in POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES 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 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES 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 204558
| Tradename: | POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES |
| Applicant: | Strides Pharma |
| Ingredient: | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous |
| Patents: | 0 |
Pharmacology for NDA: 204558
| 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: 204558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | FOR SOLUTION;ORAL | 204558 | ANDA | Strides Pharma Science Limited | 64380-765 | 64380-765-21 | 4 L in 1 JUG (64380-765-21) |
| POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | FOR SOLUTION;ORAL | 204558 | ANDA | Strides Pharma Science Limited | 64380-766 | 64380-766-21 | 4 L in 1 JUG (64380-766-21) |
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: | Dec 21, 2018 | TE: | AA | RLD: | No | ||||
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