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ACTIVE SUBSTANCE / INN

POLYETHYLENE GLYCOL 3350

Brand name(s): POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL, PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID, NULYTELY-FLAVORED, NULYTELY, GLYCOLAX, POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, OCL, PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, PEG 3350 AND ELECTROLYTES
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
NDA019284
ANDA204559
ACTIVE SUBSTANCE
Polyethylene Glycol 3350
REGULATORS
FDA
SPONSORS / MAH
AZURITY, HOSPIRA, PPI-DAC
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
POLYETHYLENE GLYCOL 3350ANDA090685PPI-DACOver-the-counter
OCLNDA019284HOSPIRADiscontinued
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESANDA204558STRIDES PHARMAPrescription
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEANDA204559STRIDES PHARMAPrescription
NULYTELYNDA019797AZURITYPrescription
NULYTELY-FLAVOREDNDA019797AZURITYPrescription
GLYCOLAXANDA076652LANNETT CO INCDiscontinued
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACIDANDA090145NOVEL LABS INCPrescription
PEG 3350 AND ELECTROLYTESANDA090186NOVEL LABS INCPrescription
POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYLANDA090197NOVEL LABS INCNone (Tentative Approval)

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