药品注册申请号:050557
申请类型:NDA (新药申请)
申请人:VALEANT INTL
申请人全名:VALEANT INTERNATIONAL SRL
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 BENZAMYCIN BENZOYL PEROXIDE; ERYTHROMYCIN GEL;TOPICAL 5%;3% Yes Yes AB 1984/10/26 1984/10/26 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
2014/12/05 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2003/01/27 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2002/08/28 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2002/03/21 SUPPL 23 Approval Manufacturing (CMC) STANDARD
2001/04/17 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2001/02/06 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2000/09/27 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1997/06/11 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1996/03/05 SUPPL 18 Approval Labeling STANDARD
1995/06/08 SUPPL 17 Approval Labeling STANDARD
1994/10/21 SUPPL 15 Approval Labeling
1993/04/13 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1993/04/07 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1989/09/15 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1984/10/26 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; ERYTHROMYCIN 剂型/给药途径:GEL;TOPICAL 规格:5%;3% 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
050557 001 NDA BENZAMYCIN BENZOYL PEROXIDE; ERYTHROMYCIN GEL;TOPICAL 5%;3% Prescription Yes Yes AB 1984/10/26 VALEANT INTL
065112 001 ANDA ERYTHROMYCIN AND BENZOYL PEROXIDE BENZOYL PEROXIDE; ERYTHROMYCIN GEL;TOPICAL 5%;3% Prescription No No AB 2004/03/29 TOLMAR
065385 001 ANDA ERYTHROMYCIN AND BENZOYL PEROXIDE BENZOYL PEROXIDE; ERYTHROMYCIN GEL;TOPICAL 5%;3% Prescription No No AB 2015/09/18 LYNE
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