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Golytely Drug - Golytely The trade name of the product as shown on the labeling. Dosage - FOR SOLUTION; 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 - 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET 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 - BRAINTREE The firm name holding legal responsibility for Golytely. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 019011 The FDA assigned number to Golytely. Format is nnnnnn. Product Number - 002 The FDA assigned number to identify Golytely. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AA The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Jun 2, 1992 The date Golytely 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) - Yes The pioneer or innovator of Golytely. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - RX The group or category of approved drugs Golytely is in. Format is RX, OTC, DISCN. Applicant Full Name - Braintree Laboratories Inc The full name of the firm holding legal responsibility for the new application of Golytely. Golytely Ocl 6gm/100ml;75mg/100ml;168mg/100ml;146mg/100ml;1.29gm/100ml Solution; Oral Colyte 120gm/packet;1.49gm/packet;3.36gm/packet;2.92gm/packet;11.36gm/packet For Solution; Oral Colyte 227.1gm/bot;2.82gm/bot;6.36gm/bot;5.53gm/bot;21.5gm/bot For Solution; Oral Colyte 227.1gm/packet;2.82gm/packet;6.36gm/packet;5.53gm/packet;21.5gm/packet For Solution; 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