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Oraqix Drug - Oraqix The trade name of the product as shown on the labeling. Dosage - GEL; PERIODONTAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Lidocaine; Prilocaine Multiple ingredients are in alphabetical order. Strength - 2.5%;2.5% The potency of the active ingredient(s), Lidocaine; Prilocaine. May repeat for multiple part products. Applicant - DENTSPLY PHARM The firm name holding legal responsibility for Oraqix. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 021451 The FDA assigned number to Oraqix. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Oraqix. 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 - Dec 19, 2003 The date Oraqix 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 Oraqix. 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 Oraqix is in. Format is RX, OTC, DISCN. Applicant Full Name - Dentsply Pharmaceutical The full name of the firm holding legal responsibility for the new application of Oraqix. Oraqix Terramycin 2%;125mg/ml Injectable; Injection Terramycin 2%;50mg/ml Injectable; Injection Emla 2.5%;2.5% Cream; Topical Lidocaine And Prilocaine 2.5%;2.5% Cream; Topical Lidocaine And Prilocaine 2.5%;2.5% Cream; Topical Lidocaine And Prilocaine 2.5%;2.5% Cream; Topical Emla 2.5%;2.5% Disc; Topical Oraqix 2.5%;2.5% Gel; Periodontal Pediatric Lta Kit 2% Solution; Topical Xylocaine 4% Preservative Free 4% Solution; Topical NewDrugInformation