药品注册申请号:019931
申请类型:NDA (新药申请)
申请人:VALEANT PHARMS NORTH
申请人全名:VALEANT PHARMACEUTICALS NORTH AMERICA LLC
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 KLARON SULFACETAMIDE SODIUM LOTION;TOPICAL 10% Yes Yes AB 1996/12/23 1996/12/23 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/02/16 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2015/10/27 SUPPL 23 Approval Manufacturing (CMC) STANDARD
2014/12/05 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2010/07/02 SUPPL 19 Approval Labeling UNKNOWN
2003/02/21 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2002/10/09 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2002/10/09 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2002/09/12 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2002/09/12 SUPPL 4 Approval Manufacturing (CMC) STANDARD
2002/03/26 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1999/06/15 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1996/12/23 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
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:SULFACETAMIDE SODIUM 剂型/给药途径:LOTION;TOPICAL 规格:10% 治疗等效代码:AB
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
019931 001 NDA KLARON SULFACETAMIDE SODIUM LOTION;TOPICAL 10% Prescription Yes Yes AB 1996/12/23 VALEANT PHARMS NORTH
077015 001 ANDA SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM LOTION;TOPICAL 10% Prescription No No AB 2006/11/17 FOUGERA PHARMS
078649 001 ANDA SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM LOTION;TOPICAL 10% Prescription No No AB 2009/03/23 PERRIGO CO TENNESSEE
078668 001 ANDA SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM LOTION;TOPICAL 10% Prescription No No AB 2009/05/20 TARO
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