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Cortef Acetate Drug - Cortef Acetate The trade name of the product as shown on the labeling. Dosage - OINTMENT; TOPICAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Hydrocortisone Acetate Multiple ingredients are in alphabetical order. Strength - 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** The potency of the active ingredient(s), Hydrocortisone Acetate. May repeat for multiple part products. Applicant - PHARMACIA AND UPJOHN The firm name holding legal responsibility for Cortef Acetate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 008917 The FDA assigned number to Cortef Acetate. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Cortef Acetate. 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 Cortef Acetate 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 Cortef Acetate. 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 Cortef Acetate is in. Format is RX, OTC, DISCN. Applicant Full Name - Pharmacia And Upjohn Co The full name of the firm holding legal responsibility for the new application of Cortef Acetate. Cortef Acetate Hydrocortone 50mg/ml Injectable; Injection Dricort 0.5% Lotion; Topical Hydrocortisone Acetate 0.5% Ointment; Ophthalmic Hydrocortone 1.5% Ointment; Ophthalmic, Otic Cortef Acetate 1% Ointment; Topical Cortef Acetate 2.5% **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Ointment; Topical Hydrocortisone Acetate 25mg/ml Injectable; Injection Hydrocortisone Acetate 50mg/ml Injectable; Injection Hydrocortisone Acetate 50mg/ml Injectable; Injection Hydrocortone 25mg/ml Injectable; Injection NewDrugInformation