药品注册申请号:017340
申请类型:NDA (新药申请)
申请人:VALEANT PHARMS NORTH
申请人全名:VALEANT PHARMACEUTICALS NORTH AMERICA LLC
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 TRETINOIN CREAM;TOPICAL 0.1% Yes Yes AB 1973/01/26 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
2016/05/13 SUPPL 48 Approval Manufacturing (CMC) STANDARD
2015/12/17 SUPPL 47 Approval Manufacturing (CMC) STANDARD
2013/01/08 SUPPL 46 Approval Manufacturing (CMC) STANDARD
2002/12/06 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2002/06/10 SUPPL 36 Approval Labeling STANDARD
2002/06/10 SUPPL 33 Approval Labeling STANDARD
2002/06/10 SUPPL 32 Approval Labeling STANDARD
2001/03/20 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1999/01/25 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1998/07/23 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1992/01/24 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1990/08/28 SUPPL 28 Approval Labeling
1990/08/28 SUPPL 27 Approval Labeling
1990/07/03 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1989/12/01 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1989/04/12 SUPPL 25 Approval Labeling
1986/08/26 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1986/07/24 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1985/06/11 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1984/03/30 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1983/06/06 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1982/12/13 SUPPL 17 Approval Labeling
1981/07/28 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1978/12/04 SUPPL 15 Approval Labeling
1977/01/04 SUPPL 14 Approval Labeling
1976/06/30 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1974/08/27 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1974/04/15 SUPPL 9 Approval Supplement STANDARD
1974/04/15 SUPPL 7 Approval Supplement STANDARD
1973/01/26 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:CREAM;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
017340 001 NDA RETIN-A TRETINOIN CREAM;TOPICAL 0.1% Prescription Yes Yes AB Approved Prior to Jan 1, 1982 VALEANT PHARMS NORTH
075213 001 ANDA TRETINOIN TRETINOIN CREAM;TOPICAL 0.1% Prescription No No AB 1998/12/24 PERRIGO PHARMA INTL
211645 001 ANDA TRETINOIN TRETINOIN CREAM;TOPICAL 0.1% Prescription No No AB 2019/01/22 TARO PHARMS
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