药品注册申请号:017579
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
002 RETIN-A TRETINOIN GEL;TOPICAL 0.025% Yes Yes AB 1975/04/18 Approved Prior to Jan 1, 1982 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
2013/05/14 SUPPL 32 Approval Manufacturing (CMC) STANDARD
2002/06/10 SUPPL 23 Approval Labeling STANDARD
2002/06/10 SUPPL 20 Approval Labeling STANDARD
2002/06/10 SUPPL 18 Approval Labeling STANDARD
2001/03/20 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1999/01/25 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1998/07/23 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1992/01/31 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1990/08/28 SUPPL 14 Approval Labeling
1990/08/28 SUPPL 13 Approval Labeling
1990/07/03 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1989/12/01 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1986/07/23 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1985/06/11 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1982/11/30 SUPPL 8 Approval Labeling
1981/07/29 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1980/04/28 SUPPL 5 Approval Labeling
1979/10/23 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1978/12/01 SUPPL 3 Approval Labeling
1977/06/14 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1977/01/04 SUPPL 1 Approval Labeling
1975/04/18 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
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:0.025% 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
017579 002 NDA RETIN-A TRETINOIN GEL;TOPICAL 0.025% Prescription Yes Yes AB Approved Prior to Jan 1, 1982 VALEANT INTL
075529 001 ANDA TRETINOIN TRETINOIN GEL;TOPICAL 0.025% Prescription No No AB 2000/02/22 PERRIGO PHARMA INTL
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