药品注册申请号:019408
申请类型:NDA (新药申请)
申请人:SCHERING
申请人全名:SCHERING CORP SUB SCHERING PLOUGH CORP
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 DIPROLENE BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL EQ 0.05% BASE No No None 1986/01/31 1986/01/31 Discontinued
002 DIPROLENE BETAMETHASONE DIPROPIONATE GEL, AUGMENTED;TOPICAL EQ 0.05% BASE No No None 1991/11/22 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
2007/12/07 SUPPL 15 Approval Labeling STANDARD
2007/12/07 SUPPL 9 Approval Labeling STANDARD
2007/12/07 SUPPL 3 Approval Labeling
1999/05/14 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1998/11/10 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1998/07/31 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1998/06/15 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1998/06/15 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1995/11/30 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1993/12/08 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1991/11/22 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1990/08/01 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1989/05/24 SUPPL 4 Approval Labeling
1987/02/24 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1986/05/13 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1986/01/31 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
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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