药品注册申请号:061954
申请类型:ANDA (仿制药申请)
申请人:TEVA
申请人全名:TEVA PHARMACEUTICALS USA 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
002 MYCO-TRIACET II NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% No No None 1985/09/20 1985/09/20 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
2001/08/30 SUPPL 35 Approval Manufacturing (CMC)
1997/08/19 SUPPL 34 Approval Manufacturing (CMC)
1996/10/31 SUPPL 33 Approval Manufacturing (CMC)
1996/06/13 SUPPL 32 Approval Manufacturing (CMC)
1996/04/12 SUPPL 31 Approval Manufacturing (CMC)
1995/07/05 SUPPL 30 Approval Manufacturing (CMC)
1995/07/05 SUPPL 29 Approval Manufacturing (CMC)
1995/07/05 SUPPL 28 Approval Manufacturing (CMC)
1995/06/30 SUPPL 27 Approval Manufacturing (CMC)
1995/05/04 SUPPL 26 Approval Manufacturing (CMC)
1995/05/04 SUPPL 25 Approval Manufacturing (CMC)
1995/02/15 SUPPL 24 Approval Manufacturing (CMC)
1993/12/03 SUPPL 23 Approval Manufacturing (CMC)
1993/12/03 SUPPL 22 Approval Manufacturing (CMC)
1993/12/03 SUPPL 21 Approval Manufacturing (CMC)
1993/12/03 SUPPL 20 Approval Manufacturing (CMC)
1993/10/21 SUPPL 16 Approval Manufacturing (CMC)
1993/10/21 SUPPL 15 Approval Manufacturing (CMC)
1993/10/21 SUPPL 14 Approval Manufacturing (CMC)
1993/10/21 SUPPL 13 Approval Manufacturing (CMC)
1993/08/31 SUPPL 19 Approval Manufacturing (CMC)
1993/08/31 SUPPL 18 Approval Manufacturing (CMC)
1993/08/31 SUPPL 17 Approval Manufacturing (CMC)
1993/08/10 SUPPL 11 Approval Manufacturing (CMC)
1993/08/04 SUPPL 12 Approval Labeling
1992/01/13 SUPPL 10 Approval Manufacturing (CMC)
1989/07/26 SUPPL 9 Approval Manufacturing (CMC)
1988/12/16 SUPPL 7 Approval Manufacturing (CMC)
1985/09/20 ORIG 1 Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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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