药品注册申请号:076434
申请类型:ANDA (仿制药申请)
申请人:SUNSTAR AMERICAS
申请人全名:SUNSTAR AMERICAS INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 PAROEX CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% No No AT 2005/11/29 2005/11/29 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2014/05/02 SUPPL-2(补充) Approval Labeling
2005/11/29 ORIG-1(原始申请) Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:CHLORHEXIDINE GLUCONATE 剂型/给药途径:SOLUTION;DENTAL 规格:0.12% 治疗等效代码:AT
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
019028 001 NDA PERIDEX CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Prescription Yes Yes AT 1986/08/13 3M
074522 001 ANDA CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Prescription No No AT 1995/12/15 PHARM ASSOC
074291 001 ANDA CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Prescription No No AT 1995/12/28 LYNE
074356 001 ANDA CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Discontinued No No AT 1996/05/07 SAPTALIS PHARMS
075561 001 ANDA CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Prescription No No AT 2000/11/14 BAJAJ
075006 001 ANDA CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Prescription No No AT 2004/03/03 CHARTWELL RX
076434 001 ANDA PAROEX CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Discontinued No No AT 2005/11/29 SUNSTAR AMERICAS
077789 001 ANDA CHLORHEXIDINE GLUCONATE CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Prescription No No AT 2009/06/18 XTTRIUM
203212 001 ANDA PERIOGARD CHLORHEXIDINE GLUCONATE SOLUTION;DENTAL 0.12% Prescription No No AT 2016/01/28 COLGATE-PALMOLIVE CO
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