Web NewDrugInformation.com

Emla Drug - Emla The trade name of the product as shown on the labeling. Dosage - DISC; TOPICAL 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 - ASTRAZENECA The firm name holding legal responsibility for Emla. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 020962 The FDA assigned number to Emla. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Emla. 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 - Feb 4, 1998 The date Emla 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) - No The pioneer or innovator of Emla. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - DISCN The group or category of approved drugs Emla is in. Format is RX, OTC, DISCN. Applicant Full Name - Astrazeneca Lp The full name of the firm holding legal responsibility for the new application of Emla. Emla 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 Pediatric Lta Kit 2% Solution; Topical Pediatric Lta Kit 2% Solution; Topical Xylocaine 4% Preservative Free 4% Solution; Topical NewDrugInformation