药品注册申请号:016763
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
001 SULFAMYLON MAFENIDE ACETATE CREAM;TOPICAL EQ 85MG BASE/GM Yes Yes None 1969/01/24 Approved Prior to Jan 1, 1982 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
2002/12/13 SUPPL 34 Approval Manufacturing (CMC) PRIORITY
2000/08/31 SUPPL 33 Approval Manufacturing (CMC) PRIORITY
1999/01/13 SUPPL 32 Approval Manufacturing (CMC) PRIORITY
1998/04/30 SUPPL 31 Approval Manufacturing (CMC) PRIORITY
1994/10/14 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
1994/09/02 SUPPL 29 Approval Manufacturing (CMC) PRIORITY
1990/12/04 SUPPL 28 Approval Manufacturing (CMC) PRIORITY
1988/11/01 SUPPL 25 Approval Labeling
1988/03/23 SUPPL 26 Approval Manufacturing (CMC) PRIORITY
1984/12/11 SUPPL 23 Approval Labeling
1983/11/03 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1983/08/24 SUPPL 22 Approval Labeling
1983/05/09 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
1981/04/28 SUPPL 20 Approval Manufacturing (CMC) PRIORITY
1980/07/23 SUPPL 19 Approval Manufacturing (CMC) PRIORITY
1977/01/26 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1977/01/11 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1976/07/28 SUPPL 15 Approval Labeling
1969/01/24 ORIG 1 Approval Type 2 - New Active Ingredient PRIORITY
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
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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