药品注册申请号:019579
申请类型:NDA (新药申请)
申请人:JANSSEN PHARMS
申请人全名:JANSSEN PHARMACEUTICALS 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 TERAZOL 7 TERCONAZOLE CREAM;VAGINAL 0.4% Yes No None 1987/12/31 1987/12/31 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
2014/07/23 SUPPL 37 Approval Labeling STANDARD
2013/09/26 SUPPL 35 Approval Labeling STANDARD
2013/07/23 SUPPL 36 Approval Manufacturing (CMC) STANDARD
2004/06/30 SUPPL 26 Approval Labeling STANDARD
2003/09/24 SUPPL 25 Approval Labeling STANDARD
2003/03/11 SUPPL 20 Approval Labeling STANDARD
2003/03/11 SUPPL 16 Approval Labeling STANDARD
2002/10/04 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2001/12/10 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2001/09/21 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2001/03/13 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2000/02/22 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1999/11/01 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1999/10/08 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1999/10/08 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1998/10/07 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1997/07/28 SUPPL 10 Approval Labeling STANDARD
1994/10/17 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1993/02/09 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1992/09/24 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1990/08/21 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1990/08/21 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1989/12/06 SUPPL 3 Approval Labeling
1989/12/06 SUPPL 1 Approval Labeling
1989/07/28 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1989/04/03 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1987/12/31 ORIG 1 Approval Type 1 - New Molecular Entity 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
本品无治疗等效药品
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