FDA Approval Activities for this Drug…

M-Zole 3 Combination Pack [Miconazole Nitrate Vaginal Suppositories and Miconazole (Combination package)], OTC, Alpharma 74-926 Miconazole Nitrate Vaginal Suppositories and Miconazole Nitrate (Combination Package) L. Perrigo Company 75-329 Monistat 1 Combination Pak, OTC Personal Products 21-308/S5 11/20/02 12/9/02 Monistat 1 Combination Pak, OTC Personal Products 21-308/S4 9/6/02 9/12/02 Monistat 1 Combination Pak, OTC Personal Products 21-308 6/29/01 11/6/01 11/6/01 11/7/01 Monistat 3 Vaginal Cream (Miconazole Nitrate), OTC Personal Products 20-827/S6 8/7/02 8/12/02 Monistat 3 Vaginal Cream (Miconazole Nitrate), OTC Advanced Care Products 20-827 3/30/98 7/18/01 Monistat 3 Combination Pak, Personal Products 20-670/S11 1/9/03 1/23/03 Monistat 3 Combination Pak, Personal Products 21-261/S4 6/17/03 7/8/03 Monistat 3 Combination Pak, Personal Products 21-261 2/2/01 8/21/01 Monistat 3 Indication: Treatment of vaginal yeast infections and relief of external itching and irritation due to a vaginal yeast infection. Monistat 7 Cream Combination Pak, Personal Products 17-450/S52 8/7/02 8/12/02 8/7/02 Monistat Dual-Pak Advanced Care Products 20-968 6/30/99 7/2/99 7/2/99 7/3/00 Monistat Indication: Treatment of vulvovaginal candidiasis. MICONAZOLE NITRATE Cream; Topical 2% MONISTAT-DERM JOHNSON AND JOHNSON 073508 MICONAZOLE NITRATE Suppository; Vaginal MICONAZOLE NITRATE ALPHARMA US 018888 MICONAZOLE NITRATE Suppository; Vaginal MONISTAT 3 ORTHO MCNEIL Monistat 1 Combination Pak, Personal Products Miconazole 3 Vaginal Antifungal Cream, Miconazole Nitrate Cream USP, L. Perrigo Company Miconazole Nitrate Suppositories and Miconazole Nitrate Cream USP, G & W Laboratories | Monistat 1 Combination Pack, Personal Products, New Dosage Regimen | Monistat 1 Combination Pack, Personal Products Co., New Dosage Regimen | Miconazole 3 (Miconazole Nitrate) Vaginal Cream, Taro Pharmaceuticals, Approval

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