Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Ciclopirox Topical Suspension, Taro Pharma, Approval | Ciclopirox Olamine Cream, Perrigo Co., Approval | LOPROX (ciclopirox) Shampoo, Medicis Pharma, Labeling Revision | Ciclopirox Topical Solution, QLT Inc., Tentative Approval | Ciclopirox Topical Solution, Perrigo Co., Tentative Approval | Ciclopirox Topical Suspension, Perrigo, Approval | Ciclopirox Topical Solution, Taro Pharma, Tentative Approval | Ciclopirox Topical Solution, Hi-Tech Phamacal, Tentative Approval | Ciclopirox Topical Solution, Actavis Mid-Atlantic, Tentative Approval | Ciclopirox Topical Solution, G & W Labs, Tentative Approval | Ciclopirox Topical Solution, Watson Labs, Tentative Approval | Ciclopirox Topical Solution, Synerx Pharma, Approval | Ciclopirox Topical Solution, Hi-Tech Pharmacal, Approval | Ciclopirox Topical Solution, Teva Pharma, Approval | Ciclopirox Topical Solution, G & W Labs, Approval | Ciclopirox Topical Solution, Taro Pharma, Approval | Ciclopirox Topical Solution, Watson Labs, Approval | Ciclopirox Topical Solution, Perrigo Co., Approval | Ciclopirox Topical Solution, Tolmar Inc., Approval | Ciclopirox Topical Solution, Apotex, Approval | Ciclopirox Topical Solution, Actavis, Approval | Ciclopirox Topical Gel, Nycomed US, Inc., Tentative Approval | Ciclopirox Gel, Nycomed US, Inc., Approval ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com