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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 | Polyethylene Glycol 3350 Powder, Teva Pharma, Approval | Polyethylene Glycol 3350 Powder, Kali Labs, Approval | Polyethylene Glycol 3350 Powder, YVR Therapeutics, Approval | MiraLAX (polyethylene glycol 3350) powder solution, Braintree Labs, Approval | HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350 sodium bicarbonate & potassium chloride), Braintree Labs, New Dosage Regimen | ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE FOR SOLUTION; ORAL 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM MOVIPREP SALIX PHARMS | MoviPrep Oral solution, Salix Pharma, Labeling Revision | Miralax (polyethylene glycol 3350), Oral Solution, Schering-Plough HealthCare Products, Package Change | Polyethylene Glycol-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride, Novel Laboratories, Inc., Approval | PEG 3350 and Electrolytes Oral Solution, Novel Laboratories, Inc., Approval | Polyethylene Glycol 3350 IV Powder, Mylan Pharmaceuticals, Inc., Tentative Approval | Polyethylene Glycol 3350 Oral Solution, Novel Laboratories, Inc., Tentative Approval | Polyethylene Glycol 3350 Powder for Solution, Nexgen Pharma, Inc., Approval | Polyethylene Glycol 3350 Oral Solution, Paddock Laboratories, Inc., Approval | Polyethylene Glycol 3350 Oral Solution, Mylan Pharmaceuticals, Inc., Approval | PEG 3350 and Electrolytes (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous) Oral Solution, Mylan Pharmaceuticals Inc., Approval | Polyethylene Glycol 3350 and Electrolytes Oral Solution, Paddock Laboratories, Approval | Lax-Lyte with Flavor Packs (Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride) Oral Solution, Paddock Laboratories, Inc., Approval | Miralax (polyethylene glycol 3350) Oral Solution, Schering-Plough HealthCare Products, Inc., Labeling Revision | Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbomate, Potassium Chloride and Bisacodyl Oral Solution and Delayed-Release Tablets, Novel Laboratories, Inc., Tentative Approval | Clenz-Lyte (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate) Oral Solution , Paddock Laboratories, Inc., Approval | HalfLytely (bisacodyl, polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride) Delayed-Release Tablet, Braintree Laboratories, Inc., Efficacy Supplement with Clinical Data to Support | MoviPrep (sodium sulfate, sodium chloride, sodium ascorbate, potassium chloride, polyethylene glycol 3500 and ascorbic acid), Oral Solution, Salix Pharmaceuticals, Inc., Labeling Revision | MoviPrep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) Oral Solution, Salix Pharmaceuticals, Inc., Labeling Revision
  
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