药品注册申请号:019137
申请类型:NDA (新药申请)
申请人:FOUGERA PHARMS
申请人全名:FOUGERA PHARMACEUTICALS 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 BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM;TOPICAL EQ 0.05% BASE Yes Yes AB 1984/10/26 1984/06/26 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
2014/09/04 SUPPL 14 Approval Manufacturing (CMC)
1997/12/05 SUPPL 12 Approval Manufacturing (CMC)
1996/03/07 SUPPL 11 Approval Manufacturing (CMC)
1995/08/17 SUPPL 10 Approval Labeling
1988/10/31 SUPPL 9 Approval Manufacturing (CMC)
1988/10/31 SUPPL 8 Approval Manufacturing (CMC)
1988/10/31 SUPPL 7 Approval Manufacturing (CMC)
1987/10/20 SUPPL 5 Approval Manufacturing (CMC)
1987/07/06 SUPPL 6 Approval Manufacturing (CMC)
1986/03/28 SUPPL 1 Approval Manufacturing (CMC)
1986/03/18 SUPPL 2 Approval Manufacturing (CMC)
1984/10/26 ORIG 1 Approval
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;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
019137 001 NDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM;TOPICAL EQ 0.05% BASE Prescription Yes Yes AB 1984/06/26 FOUGERA PHARMS
070885 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM;TOPICAL EQ 0.05% BASE Prescription No No AB 1987/02/03 ACTAVIS MID ATLANTIC
073552 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM;TOPICAL EQ 0.05% BASE Prescription No No AB 1992/04/30 TARO
210217 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM;TOPICAL EQ 0.05% BASE Prescription No No AB 2018/10/12 COSETTE
208885 001 ANDA BETAMETHASONE DIPROPIONATE BETAMETHASONE DIPROPIONATE CREAM;TOPICAL EQ 0.05% BASE Prescription No No AB 2019/01/11 ZYDUS PHARMS
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