Web NewDrugInformation.com

Maxitrol Drug - Maxitrol The trade name of the product as shown on the labeling. Dosage - SUSPENSION/DROPS; OPHTHALMIC The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate Multiple ingredients are in alphabetical order. Strength - 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML The potency of the active ingredient(s), Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate. May repeat for multiple part products. Applicant - ALCON The firm name holding legal responsibility for Maxitrol. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 062341 The FDA assigned number to Maxitrol. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Maxitrol. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AT The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - May 22, 1984 The date Maxitrol 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 Maxitrol. 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 Maxitrol 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 Maxitrol. Maxitrol 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 Neomycin Sulfate-dexamethasone Sodium Phosphate Eq 0.1% Phosphate;eq 3.5mg Base/ml Solution/drops; Ophthalmic Dexacidin 0.1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Dexasporin 0.1%;eq 3.5mg Base/gm;10,000 Units/gm 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