Details for New Drug Application (NDA): 090231
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NDA 090231 describes PEG 3350 AND ELECTROLYTES, which is a drug marketed by Novel Labs Inc and Rising and is included in three NDAs. It is available from two suppliers. Additional details are available on the PEG 3350 AND ELECTROLYTES profile page.
The generic ingredient in PEG 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 PEG 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 090231
| Tradename: | PEG 3350 AND ELECTROLYTES |
| Applicant: | Novel Labs Inc |
| Ingredient: | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous |
| Patents: | 0 |
Pharmacology for NDA: 090231
| 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: 090231
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEG 3350 AND ELECTROLYTES | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | FOR SOLUTION;ORAL | 090231 | ANDA | Novel Laboratories, Inc. | 40032-090 | 40032-090-19 | 274.31 g in 1 BOTTLE (40032-090-19) |
| PEG 3350 AND ELECTROLYTES | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | FOR SOLUTION;ORAL | 090231 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-090 | 43386-090-19 | 274.31 g in 1 BOTTLE (43386-090-19) |
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: | Jun 1, 2009 | TE: | AA | RLD: | No | ||||
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