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Synalar Drug - Synalar 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 - 0.025% 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. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 012787 The FDA assigned number to Synalar. Format is nnnnnn. Product Number - 005 The FDA assigned number to identify Synalar. 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 - Approved Prior to Jan 1, 1982 The date Synalar 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 Synalar. 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 Synalar 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. Synalar 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 Fluocinolone Acetonide 0.025% Cream; Topical Fluocinolone Acetonide 0.025% Cream; Topical Fluocinolone Acetonide 0.01% Cream; Topical NewDrugInformation