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Chloraprep One-step Frepp Drug - Chloraprep One-step Frepp The trade name of the product as shown on the labeling. Dosage - SPONGE; TOPICAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Chlorhexidine Gluconate; Isopropyl Alcohol Multiple ingredients are in alphabetical order. Strength - 2%;70% (1.5ML) The potency of the active ingredient(s), Chlorhexidine Gluconate; Isopropyl Alcohol. May repeat for multiple part products. Applicant - MEDI FLEX INC The firm name holding legal responsibility for Chloraprep One-step Frepp. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 020832 The FDA assigned number to Chloraprep One-step Frepp. Format is nnnnnn. Product Number - 003 The FDA assigned number to identify Chloraprep One-step Frepp. 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 - Apr 26, 2002 The date Chloraprep One-step Frepp 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 Chloraprep One-step Frepp. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - OTC The group or category of approved drugs Chloraprep One-step Frepp is in. Format is RX, OTC, DISCN. Applicant Full Name - Medi Flex Hosp Products Inc The full name of the firm holding legal responsibility for the new application of Chloraprep One-step Frepp. Chloraprep One-step Frepp Microderm 4% Sponge; Topical Pharmaseal Scrub Care 4% Sponge; Topical Periochip 2.5mg Tablet; Dental Chloraprep One-step 2%;70% (10.5ml) Sponge; Topical Chloraprep One-step 2%;70% (3ml) Sponge; Topical Chloraprep One-step Frepp 2%;70% (1.5ml) Sponge; Topical Chlorhexidine Gluconate 4% Sponge; Topical Chlorhexidine Gluconate 4% Sponge; Topical E-z Scrub 4% Sponge; Topical Hibiclens 4% Sponge; Topical NewDrugInformation