药品注册申请号:019555
申请类型:NDA (新药申请)
申请人:MERCK SHARP DOHME
申请人全名:MERCK SHARP AND DOHME 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 AF BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL EQ 0.05% BASE Yes No None 1987/04/27 1987/04/27 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
2019/05/01 SUPPL 35 Approval Labeling STANDARD
2018/03/28 SUPPL 34 Approval Labeling STANDARD
2014/08/13 SUPPL 33 Approval Labeling STANDARD
2006/08/28 SUPPL 26 Approval Efficacy STANDARD
2001/10/03 SUPPL 16 Approval Efficacy STANDARD
2001/10/03 SUPPL 8 Approval Labeling
2001/04/04 SUPPL 17 Approval Manufacturing (CMC) STANDARD
2000/08/14 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1999/05/14 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1998/12/07 SUPPL 12 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 10 Approval Manufacturing (CMC) STANDARD
1995/11/30 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1990/08/01 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1990/06/29 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1989/05/24 SUPPL 5 Approval Labeling
1988/11/08 SUPPL 4 Approval Labeling
1987/10/29 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1987/04/27 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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