| Betterchem |

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| FDA approval activities
for this prescription 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. |
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