FDA Approval Activities for this Drug…

Ketoconazole Cream, 2%, Teva ANDA 75-581 4/25/00 4/28/00 12/6/01 Ketoconazole Tablets USP, 200 mg, Torpharm ANDA 75-912 1/10/02 Ketoconazole Tablets USP, 200 mg, Novopharm Limited ANDA 74-971 6/15/99 6/17/99 1/10/02 Ketoconazole Tablets, 200 mg, Teva USA ANDA 75-273 6/15/99 6/17/99 12/26/01 Ketoconazole Tablets, 200 mg Mutual Pharmaceutical Compamy, ANDA 75-314 6/15/99 6/17/99 Ketoconazole Tablets, 200 mg Taro ANDA 75-319 6/15/99 6/17/99 Ketoconazole Tablets USP, 200 mg Applied Analytical Industries ANDA 75-341 7/27/99 7/29/99 Ketoconazole Tablets, 200 mg Sidmak , ANDA 75-362 6/15/99 6/17/99 Ketoconazole Tablets USP,200 mg. Mylan ANDA 75-597 Ketozole (Ketoconazole) Cream, 2 %, Taro ANDA 75-638 KETOCONAZOLE Cream; Topical 2% NIZORAL JANSSEN 075638 KETOCONAZOLE Cream; Topical 2% KETOZOLE Taro 075581 KETOCONAZOLE Cream; Topical 2% KETOCONAZOLE Teva 019927 KETOCONAZOLE Shampoo; Topical 2% NIZORAL MCNEIL CONS SPECLT 075341 KETOCONAZOLE Tablet; 200MG KETOCONAZOLE AAIPHARMA 018533 KETOCONAZOLE Tablet; 200MG NIZORAL JANSSEN 075314 KETOCONAZOLE Tablet; 200MG KETOCONAZOLE Mutual 075597 KETOCONAZOLE Tablet; 200MG KETOCONAZOLE Mylan 075362 KETOCONAZOLE Tablet; 200MG KETOCONAZOLE Pliva 075319 KETOCONAZOLE Tablet; 200MG KETOCONAZOLE Taro 075273 KETOCONAZOLE Tablet; 200MG KETOCONAZOLE Teva 074971 KETOCONAZOLE Tablet; 200MG KETOCONAZOLE Teva 075912 KETOCONAZOLE Tablet; 200MG KETOCONAZOLE Torpharm Ketoconazole Cream, Altana, Inc. | Ketoconazole Shampoo, QLT, Approval

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