Colyte - POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATE ANHYDROUS
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Field |
Value |
NDC Code: |
68220-133 |
Proprietary Name: |
Colyte |
Suffix: |
|
Non-Proprietary Name: |
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, and SODIUM SULFATE ANHYDROUS |
Dosage Form: |
POWDER, FOR SOLUTION |
Method: |
NASOGASTRIC; ORAL |
Original Marketing Date: |
01-09-2010 |
Category Name: |
NDA |
Application Number: |
NDA018983 |
Labeler: |
ALAVEN PHARMACEUTICAL LLC |
Substance Name: |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE |
Active Numerator Strength: |
227.1; 2.82; 6.36; 5.53; 21.5 |
Active Ingredient Unit: |
g/3.785L; g/3.785L; g/3.785L; g/3.785L; g/3.785L |
Pharm Classes: |
Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC] |
DEA Schedule: |
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