药品注册申请号:016831
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 EFUDEX FLUOROURACIL SOLUTION;TOPICAL 2% Yes Yes AT 1970/07/29 Approved Prior to Jan 1, 1982 Prescription
002 EFUDEX FLUOROURACIL SOLUTION;TOPICAL 5% Yes Yes AT Approved Prior to Jan 1, 1982 Prescription
003 EFUDEX FLUOROURACIL CREAM;TOPICAL 5% Yes Yes AB 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
2015/11/04 SUPPL 59 Approval Manufacturing (CMC) STANDARD
2015/08/18 SUPPL 58 Approval Manufacturing (CMC) STANDARD
2015/05/06 SUPPL 57 Approval Manufacturing (CMC) STANDARD
2013/12/12 SUPPL 55 Approval Manufacturing (CMC) STANDARD
2013/07/02 SUPPL 56 Approval Manufacturing (CMC) STANDARD
2006/05/10 SUPPL 51 Approval Manufacturing (CMC) N/A
2005/10/13 SUPPL 49 Approval Labeling STANDARD
2004/06/24 SUPPL 47 Approval Labeling STANDARD
2004/04/27 SUPPL 46 Approval Manufacturing (CMC) STANDARD
2002/11/27 SUPPL 43 Approval Manufacturing (CMC) STANDARD
2001/08/30 SUPPL 42 Approval Manufacturing (CMC) STANDARD
2001/07/03 SUPPL 41 Approval Manufacturing (CMC) STANDARD
2001/07/03 SUPPL 40 Approval Manufacturing (CMC) STANDARD
2001/02/12 SUPPL 39 Approval Manufacturing (CMC) STANDARD
2000/07/07 SUPPL 37 Approval Manufacturing (CMC) STANDARD
2000/07/07 SUPPL 36 Approval Manufacturing (CMC) STANDARD
2000/06/20 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2000/04/05 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1998/11/02 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1997/02/18 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1995/03/21 SUPPL 29 Approval Labeling
1993/08/05 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1993/03/04 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1988/11/30 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1987/03/26 SUPPL 17 Approval Labeling
1986/11/14 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1985/06/10 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1985/03/14 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1984/08/13 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1984/05/04 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1983/08/12 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1983/08/12 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1983/03/14 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1982/05/14 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1982/03/10 SUPPL 18 Approval Labeling
1979/12/18 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1979/10/23 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1978/11/21 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1977/12/14 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1977/12/14 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1975/06/30 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1975/05/07 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1975/05/07 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1974/09/19 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1970/07/29 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:FLUOROURACIL 剂型/给药途径:SOLUTION;TOPICAL 规格:2% 治疗等效代码:AT
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
016831 001 NDA EFUDEX FLUOROURACIL SOLUTION;TOPICAL 2% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 BAUSCH
076526 001 ANDA FLUOROURACIL FLUOROURACIL SOLUTION;TOPICAL 2% Prescription No No AT 2003/11/05 TARO
活性成分:FLUOROURACIL 剂型/给药途径:SOLUTION;TOPICAL 规格:5% 治疗等效代码:AT
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
016831 002 NDA EFUDEX FLUOROURACIL SOLUTION;TOPICAL 5% Prescription Yes Yes AT Approved Prior to Jan 1, 1982 BAUSCH
076526 002 ANDA FLUOROURACIL FLUOROURACIL SOLUTION;TOPICAL 5% Prescription No No AT 2003/11/05 TARO
活性成分:FLUOROURACIL 剂型/给药途径:CREAM;TOPICAL 规格:5% 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
016831 003 NDA EFUDEX FLUOROURACIL CREAM;TOPICAL 5% Prescription Yes Yes AB Approved Prior to Jan 1, 1982 BAUSCH
077524 001 ANDA FLUOROURACIL FLUOROURACIL CREAM;TOPICAL 5% Prescription No No AB 2008/04/11 MAYNE PHARMA
090368 001 ANDA FLUOROURACIL FLUOROURACIL CREAM;TOPICAL 5% Prescription No No AB 2010/03/05 TARO
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