商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
CICLOPIROX | 020519 | 001 | NDA | CICLOPIROX | GEL;TOPICAL | 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1997/07/21 | 1997/07/21 | ALVOGEN | Discontinued |
CICLOPIROX | 076422 | 001 | ANDA | CICLOPIROX | SUSPENSION;TOPICAL | 0.77% | No | No | 2004/08/06 | 2004/08/06 | FOUGERA PHARMS | Prescription |
CICLOPIROX | 076435 | 001 | ANDA | CICLOPIROX | CREAM;TOPICAL | 0.77% | No | No | 2004/12/29 | 2004/12/29 | FOUGERA PHARMS | Prescription |
CICLOPIROX | 076790 | 001 | ANDA | CICLOPIROX | CREAM;TOPICAL | 0.77% | No | No | 2005/04/12 | 2005/04/12 | TARO | Prescription |
CICLOPIROX | 077092 | 001 | ANDA | CICLOPIROX | SUSPENSION;TOPICAL | 0.77% | No | No | 2005/08/10 | 2005/08/10 | TARO | Prescription |
CICLOPIROX | 077364 | 001 | ANDA | CICLOPIROX | CREAM;TOPICAL | 0.77% | No | No | 2006/03/03 | 2006/03/03 | PADAGIS ISRAEL | Prescription |
CICLOPIROX | 077676 | 001 | ANDA | CICLOPIROX | SUSPENSION;TOPICAL | 0.77% | No | No | 2006/12/15 | 2006/12/15 | PADAGIS ISRAEL | Prescription |
CICLOPIROX | 077623 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | Yes | 2007/09/18 | 2007/09/18 | PADAGIS US | Prescription |
CICLOPIROX | 077687 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | ENCUBE | Prescription |
CICLOPIROX | 078046 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | CHARTWELL RX | Prescription |
CICLOPIROX | 078079 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | TEVA PHARMS | Discontinued |
CICLOPIROX | 078124 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | RISING | Prescription |
CICLOPIROX | 078144 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | TARO PHARM INDS | Prescription |
CICLOPIROX | 078172 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | ACELLA | Prescription |
CICLOPIROX | 078233 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | COSETTE | Discontinued |
CICLOPIROX | 078270 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | HIKMA | Discontinued |
CICLOPIROX | 078567 | 001 | ANDA | CICLOPIROX | SOLUTION;TOPICAL | 8% | No | No | 2007/09/18 | 2007/09/18 | MYLAN PHARMS INC | Discontinued |
CICLOPIROX | 077896 | 001 | ANDA | CICLOPIROX | GEL;TOPICAL | 0.77% | No | No | 2008/06/10 | 2008/06/10 | FOUGERA PHARMS | Prescription |
CICLOPIROX | 078266 | 001 | ANDA | CICLOPIROX | GEL;TOPICAL | 0.77% | No | No | 2009/01/07 | 2009/01/07 | PADAGIS US | Prescription |
CICLOPIROX | 090273 | 001 | ANDA | CICLOPIROX | CREAM;TOPICAL | 0.77% | No | No | 2009/11/10 | 2009/11/10 | GLENMARK PHARMS | Prescription |