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Synalar-hp Drug - Synalar-hp The trade name of the product as shown on the labeling. Dosage - CREAM; TOPICAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Fluocinolone Acetonide Multiple ingredients are in alphabetical order. Strength - 0.2% The potency of the active ingredient(s), Fluocinolone Acetonide. May repeat for multiple part products. Applicant - MEDICIS The firm name holding legal responsibility for Synalar-hp. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 016161 The FDA assigned number to Synalar-hp. Format is nnnnnn. Product Number - 002 The FDA assigned number to identify Synalar-hp. 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 - Approved Prior to Jan 1, 1982 The date Synalar-hp 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 Synalar-hp. 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 Synalar-hp is in. Format is RX, OTC, DISCN. Applicant Full Name - Medicis Pharmaceutical Corp The full name of the firm holding legal responsibility for the new application of Synalar-hp. Synalar-hp Fluocinolone Acetonide 0.025% Cream; Topical Fluonid 0.025% Cream; Topical Fluotrex 0.01% Cream; Topical Fluotrex 0.025% Cream; Topical Synalar 0.01% Cream; Topical Synalar 0.025% Cream; Topical Synalar 0.025% Cream; Topical Synalar-hp 0.2% Cream; Topical Fluocinolone Acetonide 0.025% Cream; Topical Fluocinolone Acetonide 0.01% Cream; Topical NewDrugInformation