药品注册申请号:020475
申请类型:NDA (新药申请)
申请人:VALEANT INTL
申请人全名:VALEANT INTERNATIONAL BARBADOS 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 RETIN-A MICRO TRETINOIN GEL;TOPICAL 0.1% Yes Yes AB 1997/02/07 1997/02/07 Prescription
002 RETIN-A MICRO TRETINOIN GEL;TOPICAL 0.04% Yes Yes AB 2002/05/10 Prescription
003 RETIN-A-MICRO TRETINOIN GEL;TOPICAL 0.08% Yes Yes None 2014/01/28 Prescription
004 RETIN-A-MICRO TRETINOIN GEL;TOPICAL 0.06% Yes Yes None 2017/10/23 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
2014/08/21 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2014/01/29 SUPPL 23 Approval Manufacturing (CMC) STANDARD
2014/01/28 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2013/01/08 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2009/02/26 SUPPL 13 Approval Manufacturing (CMC) N/A
2002/05/10 SUPPL 8 Approval Efficacy STANDARD
2001/03/20 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2000/04/27 SUPPL 6 Approval Labeling STANDARD
2000/04/05 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1999/11/10 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1999/04/23 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1998/11/13 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1998/11/13 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/02/07 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
001 5955109 2016/09/21 Y U-134 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5955109 2016/09/21 U-134 PDF格式**本条是由Drugfuture回溯的历史信息**
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:TRETINOIN 剂型/给药途径:GEL;TOPICAL 规格:0.1% 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
020475 001 NDA RETIN-A MICRO TRETINOIN GEL;TOPICAL 0.1% Prescription Yes Yes AB 1997/02/07 VALEANT INTL
202026 001 ANDA TRETINOIN TRETINOIN GEL;TOPICAL 0.1% Prescription No No AB 2013/07/17 MYLAN
活性成分:TRETINOIN 剂型/给药途径:GEL;TOPICAL 规格:0.04% 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
020475 002 NDA RETIN-A MICRO TRETINOIN GEL;TOPICAL 0.04% Prescription Yes Yes AB 2002/05/10 VALEANT INTL
202567 001 ANDA TRETINOIN TRETINOIN GEL;TOPICAL 0.04% Prescription No No AB 2013/07/17 MYLAN
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药品NDC数据与药品包装、标签说明书
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