Details for New Drug Application (NDA): 090019
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NDA 090019 describes PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, which is a drug marketed by Nostrum Labs Inc, Novel Labs Inc, Rising, and Strides Pharma, and is included in four NDAs. It is available from two suppliers. Additional details are available on the PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE profile page.
The generic ingredient in PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are four hundred and twenty-one drug master file entries for this compound. Three 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 PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are four hundred and twenty-one drug master file entries for this compound. Three 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 090019
| Tradename: | PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
| Applicant: | Novel Labs Inc |
| Ingredient: | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 090019
| 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: 090019
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride | FOR SOLUTION;ORAL | 090019 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-050 | 43386-050-19 | 438.4 g in 1 BOTTLE (43386-050-19) |
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: | May 27, 2009 | TE: | AA | RLD: | No | ||||
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