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Nizoral A-d Drug - Nizoral A-d The trade name of the product as shown on the labeling. Dosage - SHAMPOO; TOPICAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Ketoconazole Multiple ingredients are in alphabetical order. Strength - 1% The potency of the active ingredient(s), Ketoconazole. May repeat for multiple part products. Applicant - MCNEIL CONS SPECLT The firm name holding legal responsibility for Nizoral A-d. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 020310 The FDA assigned number to Nizoral A-d. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Nizoral A-d. 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 - Oct 10, 1997 The date Nizoral A-d 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 Nizoral A-d. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - OTC The group or category of approved drugs Nizoral A-d is in. Format is RX, OTC, DISCN. Applicant Full Name - Mcneil Consumer And Specialty Pharmaceuticals Div Mcneil Pcc Inc The full name of the firm holding legal responsibility for the new application of Nizoral A-d. Nizoral A-d Nizoral 2% Cream; Topical Ketoconazole 2% Shampoo; Topical Ketoconazole 2% Shampoo; Topical Nizoral 2% Shampoo; Topical Nizoral A-d 1% Shampoo; Topical Ketamine Hcl Eq 100mg Base/ml Injectable; Injection Ketamine Hcl Eq 50mg Base/ml Injectable; Injection Ketoconazole 2% Cream; Topical Ketoconazole 2% Cream; Topical Ketozole 2% Cream; Topical NewDrugInformation