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Synera Drug - Synera The trade name of the product as shown on the labeling. Dosage - PATCH; TOPICAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Lidocaine; Tetracaine Multiple ingredients are in alphabetical order. Strength - 70MG;70MG The potency of the active ingredient(s), Lidocaine; Tetracaine. May repeat for multiple part products. Applicant - ZARS The firm name holding legal responsibility for Synera. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 021623 The FDA assigned number to Synera. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Synera. 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 - Jun 23, 2005 The date Synera 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 Synera. 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 Synera is in. Format is RX, OTC, DISCN. Applicant Full Name - Zars Inc The full name of the firm holding legal responsibility for the new application of Synera. Synera 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 Synera 70mg;70mg Patch; Topical Xylocaine 4% Preservative Free 4% Solution; Topical NewDrugInformation