FDA Approval Activities for this Drug…

Loprox (ciclopirox) Cream, 0.77%, Medicis Pharmaceutical NDA 18-748/S10 3/26/03 4/1/03 4/1/03 Loprox (ciclopirox) Gel, 0.77%, Medicis Pharmaceutical NDA 18-748/S11 8/17/01 Loprox (ciclopirox) Gel, 0.77%, Medicis Pharmaceutical NDA 20-519/S5 3/26/03 4/15/03 4/1/03 Loprox (ciclopirox) Lotion, 0.77%, Medicis Pharmaceutical NDA 19-824/S9 3/26/03 4/1/03 4/1/03 Loprox (ciclopirox) Lotion, 0.77%, Medicis Pharmaceutical NDA 19-824/S8 3/26/03 4/1/03 4/1/03 Loprox (ciclopirox) Shampoo, 1%, Medicis Pharmaceutical NDA 21-159 Penlac Nail Lacquer (ciclopirox) Topical Solution, 8%. Aventis NDA 21-022/S2 6/9/03 7/8/03 7/7/03 Penlac Nail Lacquer (ciclopirox) Topical Solution, 8%. [Package Labeling] Aventis NDA 21-022 12/17/99 12/27/99 12/27/99 8/20/02 Penlac Indications:provides for the use of PENLAC™ NAIL LACQUER (ciclopirox) Topical Solution, 8%, as a component of a comprehensive management program, for the topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. Loprox (ciclopirox) Shampoo, Medicis Pharmaceutical Corporation Ciclopirox Topical Suspension Lotion, Altana, Inc., Approval | Penlac Nail Lacquer (ciclopirox) Topical Solution, Dermik, Labeling Revision | Ciclopirox Olamine Cream, Altana, Approval

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