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
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2001/08/30 SUPPL-35(补充) Approval Manufacturing (CMC)
1997/08/19 SUPPL-34(补充) Approval Manufacturing (CMC)
1996/10/31 SUPPL-33(补充) Approval Manufacturing (CMC)
1996/06/13 SUPPL-32(补充) Approval Manufacturing (CMC)
1996/04/12 SUPPL-31(补充) Approval Manufacturing (CMC)
1995/07/05 SUPPL-30(补充) Approval Manufacturing (CMC)
1995/07/05 SUPPL-29(补充) Approval Manufacturing (CMC)
1995/07/05 SUPPL-28(补充) Approval Manufacturing (CMC)
1995/06/30 SUPPL-27(补充) Approval Manufacturing (CMC)
1995/05/04 SUPPL-26(补充) Approval Manufacturing (CMC)
1995/05/04 SUPPL-25(补充) Approval Manufacturing (CMC)
1995/02/15 SUPPL-24(补充) Approval Manufacturing (CMC)
1993/12/03 SUPPL-23(补充) Approval Manufacturing (CMC)
1993/12/03 SUPPL-22(补充) Approval Manufacturing (CMC)
1993/12/03 SUPPL-21(补充) Approval Manufacturing (CMC)
1993/12/03 SUPPL-20(补充) Approval Manufacturing (CMC)
1993/10/21 SUPPL-16(补充) Approval Manufacturing (CMC)
1993/10/21 SUPPL-15(补充) Approval Manufacturing (CMC)
1993/10/21 SUPPL-14(补充) Approval Manufacturing (CMC)
1993/10/21 SUPPL-13(补充) Approval Manufacturing (CMC)
1993/08/31 SUPPL-19(补充) Approval Manufacturing (CMC)
1993/08/31 SUPPL-18(补充) Approval Manufacturing (CMC)
1993/08/31 SUPPL-17(补充) Approval Manufacturing (CMC)
1993/08/10 SUPPL-11(补充) Approval Manufacturing (CMC)
1993/08/04 SUPPL-12(补充) Approval Labeling
1992/01/13 SUPPL-10(补充) Approval Manufacturing (CMC)
1989/07/26 SUPPL-9(补充) Approval Manufacturing (CMC)
1988/12/16 SUPPL-7(补充) Approval Manufacturing (CMC)
1985/09/20 ORIG-1(原始申请) 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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