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Monistat 5 Drug - Monistat 5 The trade name of the product as shown on the labeling. Dosage - TAMPON; VAGINAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Miconazole Nitrate Multiple ingredients are in alphabetical order. Strength - 100MG The potency of the active ingredient(s), Miconazole Nitrate. May repeat for multiple part products. Applicant - PERSONAL PRODS The firm name holding legal responsibility for Monistat 5. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 018592 The FDA assigned number to Monistat 5. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Monistat 5. 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 27, 1989 The date Monistat 5 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 Monistat 5. 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 Monistat 5 is in. Format is RX, OTC, DISCN. Applicant Full Name - Personal Products Co The full name of the firm holding legal responsibility for the new application of Monistat 5. Monistat 5 Monistat 3 200mg Suppository; Vaginal Monistat 7 100mg Suppository; Vaginal Monistat 5 100mg Tampon; Vaginal Monistat 3 4% Cream; Vaginal Monistat 7 2% Cream; Vaginal Monistat-derm 2% Lotion; Topical Miconazole Nitrate 100mg Suppository; Vaginal Miconazole Nitrate 200mg Suppository; Vaginal Miconazole Nitrate 100mg Suppository; Vaginal Miconazole Nitrate 100mg Suppository; Vaginal NewDrugInformation