药品注册申请号:019832
申请类型:NDA (新药申请)
申请人:MYLAN INSTITUTIONAL
申请人全名:MYLAN INSTITUTIONAL 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
003 SULFAMYLON MAFENIDE ACETATE FOR SOLUTION;TOPICAL 5% Yes Yes AT 1998/06/05 1998/06/05 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
2015/01/20 SUPPL 14 Approval Manufacturing (CMC) STANDARD
2013/06/18 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2002/12/18 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2002/05/09 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2001/09/17 SUPPL 4 Approval Manufacturing (CMC) STANDARD
2001/07/12 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2001/07/12 SUPPL 2 Approval Labeling STANDARD
1998/09/25 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1998/06/05 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:MAFENIDE ACETATE 剂型/给药途径:FOR SOLUTION;TOPICAL 规格:5% 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
019832 003 NDA SULFAMYLON MAFENIDE ACETATE FOR SOLUTION;TOPICAL 5% Prescription Yes Yes AT 1998/06/05 MYLAN INSTITUTIONAL
201511 001 ANDA MAFENIDE ACETATE MAFENIDE ACETATE FOR SOLUTION;TOPICAL 5% Prescription No No AT 2013/02/12 PAR FORM
206716 001 ANDA MAFENIDE ACETATE MAFENIDE ACETATE FOR SOLUTION;TOPICAL 5% Prescription No No AT 2017/07/31 NOVAST LABS
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药品NDC数据与药品包装、标签说明书
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