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Tri-luma Drug - Tri-luma 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; Hydroquinone; Tretinoin Multiple ingredients are in alphabetical order. Strength - 0.01%;4%;0.05% The potency of the active ingredient(s), Fluocinolone Acetonide; Hydroquinone; Tretinoin. May repeat for multiple part products. Applicant - GALDERMA LABS LP The firm name holding legal responsibility for Tri-luma. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 021112 The FDA assigned number to Tri-luma. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Tri-luma. 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 - Jan 18, 2002 The date Tri-luma 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 Tri-luma. 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 Tri-luma is in. Format is RX, OTC, DISCN. Applicant Full Name - Galderma Laboratories Lp The full name of the firm holding legal responsibility for the new application of Tri-luma. Tri-luma Synalar 0.01% Solution; Topical Tri-luma 0.01%;4%;0.05% Cream; Topical Fluocinolone Acetonide 0.01% Solution; Topical Fluocinolone Acetonide 0.01% Solution; Topical Fluocinolone Acetonide 0.01% Solution; Topical Fluocinolone Acetonide 0.01% Solution; Topical Fluocinolone Acetonide 0.01% Solution; Topical Fluocinolone Acetonide 0.01% Solution; Topical Fluonid 0.01% Solution; Topical Fluotrex 0.01% Solution; Topical NewDrugInformation