药品注册申请号:084908
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
001 TRIACET TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.025% No No None 1976/05/24 Approved Prior to Jan 1, 1982 Discontinued
002 TRIACET TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.1% No No None Approved Prior to Jan 1, 1982 Discontinued
003 TRIACET TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 0.5% No No None Approved Prior to Jan 1, 1982 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 57 Approval Manufacturing (CMC)
2000/07/07 SUPPL 56 Approval Manufacturing (CMC)
2000/02/17 SUPPL 55 Approval Manufacturing (CMC)
1996/06/13 SUPPL 54 Approval Manufacturing (CMC)
1995/05/04 SUPPL 53 Approval Manufacturing (CMC)
1995/05/04 SUPPL 52 Approval Manufacturing (CMC)
1994/05/09 SUPPL 44 Approval Manufacturing (CMC)
1994/01/13 SUPPL 51 Approval Manufacturing (CMC)
1993/08/31 SUPPL 50 Approval Manufacturing (CMC)
1993/08/31 SUPPL 49 Approval Manufacturing (CMC)
1993/08/31 SUPPL 48 Approval Manufacturing (CMC)
1993/08/31 SUPPL 47 Approval Manufacturing (CMC)
1993/04/01 SUPPL 45 Approval Manufacturing (CMC)
1993/03/10 SUPPL 46 Approval Labeling
1989/06/28 SUPPL 43 Approval Manufacturing (CMC)
1988/09/02 SUPPL 42 Approval Manufacturing (CMC)
1985/01/29 SUPPL 39 Approval Manufacturing (CMC)
1983/04/22 SUPPL 36 Approval Manufacturing (CMC)
1983/01/31 SUPPL 35 Approval Manufacturing (CMC)
1983/01/31 SUPPL 30 Approval Manufacturing (CMC)
1982/10/15 SUPPL 32 Approval Manufacturing (CMC)
1982/10/15 SUPPL 31 Approval Manufacturing (CMC)
1982/06/07 SUPPL 34 Approval Manufacturing (CMC)
1976/05/24 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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