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Hydrocortisone Acetate 1% And Pramoxine Hcl 1% Drug - Hydrocortisone Acetate 1% And Pramoxine Hcl 1% The trade name of the product as shown on the labeling. Dosage - AEROSOL, METERED; TOPICAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Hydrocortisone Acetate; Pramoxine Hydrochloride Multiple ingredients are in alphabetical order. Strength - 1%;1% The potency of the active ingredient(s), Hydrocortisone Acetate; Pramoxine Hydrochloride. May repeat for multiple part products. Applicant - BOCA PHARMA The firm name holding legal responsibility for Hydrocortisone Acetate 1% And Pramoxine Hcl 1%. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 089440 The FDA assigned number to Hydrocortisone Acetate 1% And Pramoxine Hcl 1%. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Hydrocortisone Acetate 1% And Pramoxine Hcl 1%. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - BX The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - May 17, 1988 The date Hydrocortisone Acetate 1% And Pramoxine Hcl 1% 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 Hydrocortisone Acetate 1% And Pramoxine Hcl 1%. 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 Hydrocortisone Acetate 1% And Pramoxine Hcl 1% is in. Format is RX, OTC, DISCN. Applicant Full Name - Boca Pharmacal Inc The full name of the firm holding legal responsibility for the new application of Hydrocortisone Acetate 1% And Pramoxine Hcl 1%. Hydrocortisone Acetate 1% And Pramoxine Hcl 1% Epifoam 1%;1% Aerosol, Metered; Topical Hydrocortisone Acetate 1% And Pramoxine Hcl 1% 1%;1% Aerosol, Metered; Topical Neo-cortef 0.5%;eq 3.5mg Base/gm Ointment; Topical Neo-cortef 1%;eq 3.5mg Base/gm Ointment; Topical Neo-cortef 2.5%;eq 3.5mg Base/gm Ointment; Topical Cor-oticin 1.5%;eq 3.5mg Base/ml Suspension/drops; Ophthalmic Neo-cortef 0.5%;eq 3.5mg Base/ml Suspension/drops; Ophthalmic Neo-cortef 1.5%;eq 3.5mg Base/ml Suspension/drops; Ophthalmic Cortisporin 0.5%;eq 3.5mg Base/gm;10,000 Units/gm Cream; Topical Terra-cortril 1.5%;eq 5mg Base/ml Suspension/drops; Ophthalmic NewDrugInformation