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H-cort Drug - H-cort The trade name of the product as shown on the labeling. Dosage - POWDER; FOR RX COMPOUNDING The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Hydrocortisone Multiple ingredients are in alphabetical order. Strength - 100% The potency of the active ingredient(s), Hydrocortisone. May repeat for multiple part products. Applicant - TORCH The firm name holding legal responsibility for H-cort. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 087834 The FDA assigned number to H-cort. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify H-cort. 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 - Mar 29, 1982 The date H-cort 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 H-cort. 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 H-cort is in. Format is RX, OTC, DISCN. Applicant Full Name - Torch Laboratories Inc The full name of the firm holding legal responsibility for the new application of H-cort. H-cort Hydrocortisone 1% Ointment; Topical Hydrocortisone 2.5% Ointment; Topical Hydrocortisone In Absorbase 1% Ointment; Topical Hytone 1% Ointment; Topical Hytone 2.5% Ointment; Topical Penecort 2.5% Ointment; Topical H-cort 100% Powder; For Rx Compounding Hydrocortisone 0.5% Ointment; Topical Hydrocortisone 1% Ointment; Topical Hydrocortisone 2.5% Ointment; Topical NewDrugInformation