Details for New Drug Application (NDA): 090186
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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 090186
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: 090186
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: 090186
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 | 090186 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-060 | 43386-060-19 | 278.26 g in 1 BOTTLE (43386-060-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | ||||
Approval Date: | Jun 1, 2009 | TE: | RLD: | No |
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