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Tobradex Drug - Tobradex The trade name of the product as shown on the labeling. Dosage - OINTMENT; OPHTHALMIC The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Dexamethasone; Tobramycin Multiple ingredients are in alphabetical order. Strength - 0.1%;0.3% The potency of the active ingredient(s), Dexamethasone; Tobramycin. May repeat for multiple part products. Applicant - ALCON The firm name holding legal responsibility for Tobradex. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 050616 The FDA assigned number to Tobradex. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Tobradex. 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 - Sep 28, 1988 The date Tobradex 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 Tobradex. 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 Tobradex is in. Format is RX, OTC, DISCN. Applicant Full Name - Alcon Laboratories Inc The full name of the firm holding legal responsibility for the new application of Tobradex. Tobradex Neomycin And Polymyxin B Sulfates And Dexamethasone 0.1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Dexacidin 0.1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Dexasporin 0.1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Dexasporin 0.1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Maxitrol 0.1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Maxitrol 0.1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Neomycin And Polymyxin B Sulfates And Dexamethasone 0.1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Tobradex 0.1%;0.3% Ointment; Ophthalmic Maxitrol 0.1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Neomycin And Polymyxin B Sulfates And Dexamethasone 0.1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic NewDrugInformation