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E-z-em Prep Lyte Drug - E-z-em Prep Lyte The trade name of the product as shown on the labeling. Dosage - FOR SUSPENSION; ORAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate, Anhydrous Multiple ingredients are in alphabetical order. Strength - 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT The potency of the active ingredient(s), Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate, Anhydrous. May repeat for multiple part products. Applicant - E Z EM The firm name holding legal responsibility for E-z-em Prep Lyte. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 071278 The FDA assigned number to E-z-em Prep Lyte. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify E-z-em Prep Lyte. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Nov 21, 1988 The date E-z-em Prep Lyte was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982". Reference Listed Drug (RLD) - No The pioneer or innovator of E-z-em Prep Lyte. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - DISCN The group or category of approved drugs E-z-em Prep Lyte is in. Format is RX, OTC, DISCN. Applicant Full Name - E Z Em Co Inc The full name of the firm holding legal responsibility for the new application of E-z-em Prep Lyte. E-z-em Prep Lyte Golytely 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Solution; Oral Co-lav 240gm/bot;2.98gm/bot;6.72gm/bot;5.84gm/bot;22.72gm/bot For Suspension; Oral Colovage 227.1gm/packet;2.82gm/packet;6.36gm/packet;5.53gm/packet;21.5gm/packet For Suspension; Oral E-z-em Prep Lyte 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Suspension; Oral Colyte 240gm/bot;2.98gm/bot;6.72gm/bot;5.84gm/bot;22.72gm/bot For Solution; Oral Colyte 360gm/packet;4.47gm/packet;10.08gm/packet;8.76gm/packet;34.08gm/packet For Solution; Oral Colyte With Flavor Packs 240gm/bot;2.98gm/bot;6.72gm/bot;5.84gm/bot;22.72gm/bot For Solution; Oral Colyte-flavored 227.1gm/bot;2.82gm/bot;6.36gm/bot;5.53gm/bot;21.5gm/bot For Solution; Oral Colyte-flavored 240gm/bot;2.98gm/bot;6.72gm/bot;5.84gm/bot;22.72gm/bot For Solution; Oral Golytely 227.1gm/packet;2.82gm/packet;6.36gm/packet;5.53gm/packet;21.5gm/packet For Solution; Oral NewDrugInformation