FDA Approval Activities for this Drug…

GoLYTELY (PEG-3350 and Electrolytes) for Solution, Braintree , NDA 19-011/S-015 MiraLax (polyethylene glycol 3350, NF) Powder, Braintree , NDA 20-698 2/18/99 2/24/99 2/24/99&3/2/99 8/17/99 MiraLax Indication: For occasional constipation. Colyte (PEG and Electrolytes) Solution, Schwarz Pharma POLYETHYLENE GLYCOL 3350 For Solution; 17GM/SCOOPFUL MIRALAX BRAINTREE 019797 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE For Solution; 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT NULYTELY BRAINTREE 019797 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE For Solution; 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT NULYTELY-FLAVORED BRAINTREE 019284 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE Solution; 6GM/100ML;75MG/100ML;168MG/100ML;146MG/100ML;1.29GM/100ML OCL Abbott 019011 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Solution; 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET GOLYTELY BRAINTREE 019011 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Solution; 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT GOLYTELY BRAINTREE 018983 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Solution; 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT COLYTE SCHWARZ 018983 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Solution; 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT COLYTE-FLAVORED SCHWARZ 018983 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Solution; 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT COLYTE-FLAVORED SCHWARZ 018983 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Solution; 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT COLYTE SCHWARZ 018983 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Solution; 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT COLYTE WITH FLAVOR PACKS SCHWARZ 073433 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Suspension; 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT GO-EVAC Copley 073428 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Suspension; 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT CO-LAV Copley 071320 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Suspension; 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET COLOVAGE DYNAPHARM 071278 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Suspension; 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT E-Z-EM PREP LYTE E Z EM 072319 POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE, ANHYDROUS For Suspension; 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT GLYCOPREP GOLDLINE Polyethylene Glycol 3350 Powder, Schwarz Pharma, Inc., GlycoLax (Polyethylene Glycol 3350) Powder for Oral Solution, Schwarz Pharma, Approval MiraLax (Polyethylene Glycol 3350) Powder for Solution, Braintree, Labeling Revision

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