药品注册申请号:018818
申请类型:NDA (新药申请)
申请人:MUTUAL PHARM
申请人全名:MUTUAL PHARMACEUTICAL CO 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 METRONIDAZOLE METRONIDAZOLE TABLET;ORAL 250MG No No None 1983/02/16 1983/02/16 Discontinued
002 METRONIDAZOLE METRONIDAZOLE TABLET;ORAL 500MG No No None 1983/02/16 Discontinued
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
1998/12/01 SUPPL 32 Approval Manufacturing (CMC)
1997/05/21 SUPPL 31 Approval Labeling
1994/12/23 SUPPL 30 Approval Manufacturing (CMC)
1994/10/11 SUPPL 29 Approval Manufacturing (CMC)
1992/04/03 SUPPL 28 Approval Manufacturing (CMC)
1992/04/03 SUPPL 26 Approval Manufacturing (CMC)
1992/04/03 SUPPL 24 Approval Manufacturing (CMC)
1992/04/03 SUPPL 23 Approval Manufacturing (CMC)
1991/07/18 SUPPL 22 Approval Labeling
1991/06/07 SUPPL 21 Approval Labeling
1991/05/08 SUPPL 20 Approval Manufacturing (CMC)
1991/05/08 SUPPL 19 Approval Manufacturing (CMC)
1991/04/01 SUPPL 18 Approval Manufacturing (CMC)
1991/04/01 SUPPL 17 Approval Manufacturing (CMC)
1988/11/29 SUPPL 16 Approval Labeling
1987/04/03 SUPPL 13 Approval Manufacturing (CMC)
1986/06/13 SUPPL 10 Approval Manufacturing (CMC)
1986/06/13 SUPPL 9 Approval Manufacturing (CMC)
1986/06/13 SUPPL 8 Approval Manufacturing (CMC)
1985/07/31 SUPPL 6 Approval Manufacturing (CMC)
1985/04/02 SUPPL 2 Approval Manufacturing (CMC)
1983/02/16 ORIG 1 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
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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