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Polymyxin B Sulfate Drug - Polymyxin B Sulfate The trade name of the product as shown on the labeling. Dosage - INJECTABLE; INJECTION The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Polymyxin B Sulfate Multiple ingredients are in alphabetical order. Strength - EQ 500,000 U BASE/VIAL The potency of the active ingredient(s), Polymyxin B Sulfate. May repeat for multiple part products. Applicant - BEDFORD The firm name holding legal responsibility for Polymyxin B Sulfate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 060716 The FDA assigned number to Polymyxin B Sulfate. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Polymyxin B Sulfate. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AP The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Approved Prior to Jan 1, 1982 The date Polymyxin B Sulfate 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 Polymyxin B Sulfate. 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 Polymyxin B Sulfate is in. Format is RX, OTC, DISCN. Applicant Full Name - Bedford Laboratories Div Ben Venue Laboratories Inc The full name of the firm holding legal responsibility for the new application of Polymyxin B Sulfate. Polymyxin B Sulfate 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 Glycoprep 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Suspension; Oral Go-evac 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Suspension; Oral Peg-lyte 236gm/bot;2.97gm/bot;6.74gm/bot;5.86gm/bot;22.74gm/bot For Suspension; Oral Aerosporin Eq 500,000 U Base/vial Injectable; Injection Polymyxin B Sulfate Eq 500,000 U Base/vial Injectable; Injection Golytely 227.1gm/packet;2.82gm/packet;6.36gm/packet;5.53gm/packet;21.5gm/packet For Solution; Oral NewDrugInformation