药品注册申请号:050756
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH AMERICAS 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 BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE Yes Yes AB 2000/12/21 2000/12/21 Prescription
002 BENZACLIN BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE No No None 2007/04/20 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
2014/12/05 SUPPL 44 Approval Manufacturing (CMC) STANDARD
2014/09/22 SUPPL 43 Approval Manufacturing (CMC) STANDARD
2011/03/02 SUPPL 40 Approval Manufacturing (CMC) STANDARD
2010/06/17 SUPPL 37 Approval Labeling UNKNOWN
2010/06/14 SUPPL 35 Approval Manufacturing (CMC) N/A
2009/06/12 SUPPL 34 Approval Labeling STANDARD
2007/05/23 SUPPL 26 Approval Labeling STANDARD
2007/04/20 SUPPL 27 Approval Manufacturing (CMC) N/A
2005/04/28 SUPPL 16 Approval Labeling STANDARD
2002/08/28 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2002/08/09 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2002/06/27 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2002/03/26 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2001/10/12 SUPPL 3 Approval Manufacturing (CMC) STANDARD
2001/09/26 SUPPL 5 Approval Manufacturing (CMC) STANDARD
2001/09/25 SUPPL 4 Approval Manufacturing (CMC) STANDARD
2001/08/30 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2001/04/17 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2000/12/21 ORIG 1 Approval Type 4 - New Combination 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: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 Prescription Yes Yes 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 PERRIGO UK FINCO
204087 001 ANDA CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE GEL;TOPICAL 5%;EQ 1% BASE Prescription No No AB 2017/06/27 TOLMAR
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 No AB 2019/03/14 GLENMARK PHARMS
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