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ACTIVE SUBSTANCE / INN

SODIUM BICARBONATE

Brand name(s): OMEPRAZOLE AND SODIUM BICARBONATE, POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL, SODIUM BICARBONATE, NULYTELY-FLAVORED, NULYTELY, BSS PLUS, POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, OCL, PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, PEG 3350 AND ELECTROLYTES
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
NDA019284
ANDA204559
ACTIVE SUBSTANCE
Sodium Bicarbonate
REGULATORS
FDA
SPONSORS / MAH
ALCON, AZURITY, HOSPIRA
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
OMEPRAZOLE AND SODIUM BICARBONATEANDA201946STRIDES PHARMA INTLDiscontinued
OCLNDA019284HOSPIRADiscontinued
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESANDA204558STRIDES PHARMAPrescription
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEANDA204559STRIDES PHARMAPrescription
NULYTELYNDA019797AZURITYPrescription
NULYTELY-FLAVOREDNDA019797AZURITYPrescription
BSS PLUSNDA018469ALCONPrescription
PEG 3350 AND ELECTROLYTESANDA090186NOVEL LABS INCPrescription
POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYLANDA090197NOVEL LABS INCNone (Tentative Approval)
SODIUM BICARBONATEANDA202679HOSPIRAPrescription

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