药品注册申请号:202440
申请类型:ANDA (仿制药申请)
申请人:PADAGIS ISRAEL
申请人全名:PADAGIS ISRAEL PHARMACEUTICALS LTD
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 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE No No AB 2015/09/21 2015/09/21 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2015/09/21 ORIG-1(原始申请) 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:BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 剂型/给药途径:GEL;TOPICAL 规格:5%;EQ 1% 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
050756 001 NDA BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE Discontinued Yes No AB 2000/12/21 BAUSCH
065443 001 ANDA CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE Prescription No No AB 2009/08/11 MYLAN PHARMS INC
202440 001 ANDA CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE Prescription No No AB 2015/09/21 PADAGIS ISRAEL
208776 001 ANDA CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE Prescription No No AB 2018/05/25 TARO
209252 001 ANDA CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE Prescription No Yes AB 2019/03/14 GLENMARK PHARMS
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药品NDC数据与药品包装、标签说明书
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