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 Yes AB 1987/04/27 1987/04/27 Prescription
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)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
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
活性成分:BETAMETHASONE DIPROPIONATE 剂型/给药途径:CREAM, AUGMENTED;TOPICAL 规格:EQ 0.05% BASE 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
019555 001 NDA DIPROLENE AF BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL EQ 0.05% BASE Prescription Yes Yes AB 1987/04/27 MERCK SHARP DOHME
076215 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL EQ 0.05% BASE Prescription No No AB 2003/12/09 FOUGERA PHARMS
076543 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL EQ 0.05% BASE Prescription No No AB 2003/12/09 TARO
076592 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL EQ 0.05% BASE Prescription No No AB 2003/12/09 PERRIGO ISRAEL
076603 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL EQ 0.05% BASE Prescription No No AB 2004/01/23 ANDA REPOSITORY
078930 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED;TOPICAL EQ 0.05% BASE Prescription No No AB 2008/09/23 GLENMARK GENERICS
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