药品注册申请号:017377
申请类型:NDA (新药申请)
申请人:SUN PHARM INDUSTRIES
申请人全名:SUN PHARMACEUTICAL INDUSTRIES 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 BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Yes No AB 1973/07/30 Approved Prior to Jan 1, 1982 Prescription
002 BACTRIM DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG 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
2016/04/18 SUPPL 78 Approval Manufacturing (CMC) STANDARD
2015/11/27 SUPPL 77 Approval Manufacturing (CMC) STANDARD
2015/04/13 SUPPL 76 Approval Manufacturing (CMC) STANDARD
2015/04/07 SUPPL 75 Approval Manufacturing (CMC) STANDARD
2014/07/16 SUPPL 74 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2013/07/12 SUPPL 73 Approval Labeling STANDARD
2013/07/12 SUPPL 68 Approval Labeling UNKNOWN
2012/08/29 SUPPL 71 Approval Labeling STANDARD
2010/07/27 SUPPL 67 Approval Labeling UNKNOWN
2010/06/28 SUPPL 66 Approval Labeling STANDARD
2007/06/05 SUPPL 63 Approval Labeling STANDARD
2003/02/12 SUPPL 57 Approval Labeling STANDARD
2002/10/17 SUPPL 58 Approval Manufacturing (CMC) STANDARD
2000/07/03 SUPPL 53 Approval Labeling
2000/07/03 SUPPL 50 Approval Labeling
1998/11/17 SUPPL 56 Approval Labeling STANDARD
1996/03/06 SUPPL 47 Approval Labeling
1994/04/18 SUPPL 55 Approval Manufacturing (CMC) STANDARD
1990/07/17 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1990/06/15 SUPPL 40 Approval Efficacy
1987/08/11 SUPPL 46 Approval Labeling
1987/05/11 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1987/05/11 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1985/03/19 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1984/11/23 SUPPL 43 Approval Labeling
1984/06/12 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1984/05/09 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1983/08/01 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1983/06/15 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1982/02/23 SUPPL 32 Approval Efficacy
1981/12/09 SUPPL 36 Approval Labeling
1981/10/09 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1981/04/23 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1981/04/01 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1980/10/31 SUPPL 33 Approval Labeling
1980/03/06 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1979/12/17 SUPPL 30 Approval Labeling
1979/07/26 SUPPL 23 Approval Labeling
1979/04/18 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1978/10/11 SUPPL 27 Approval Labeling
1978/04/19 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1978/04/18 SUPPL 26 Approval Labeling
1978/03/01 SUPPL 25 Approval Labeling
1978/01/12 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1977/05/02 SUPPL 22 Approval Labeling
1977/02/15 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1977/01/19 SUPPL 21 Approval Labeling
1976/11/22 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1976/10/01 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1976/05/12 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1976/02/12 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1975/07/03 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1975/04/14 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1975/01/22 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1974/12/05 SUPPL 10 Approval Labeling
1974/12/05 SUPPL 9 Approval Labeling
1974/06/12 SUPPL 4 Approval Supplement STANDARD
1973/07/30 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer 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:SULFAMETHOXAZOLE; TRIMETHOPRIM 剂型/给药途径:TABLET;ORAL 规格:400MG;80MG 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
017376 001 NDA SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription No No AB Approved Prior to Jan 1, 1982 MONARCH PHARMS
017377 001 NDA BACTRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SUN PHARM INDUSTRIES
071017 002 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription No No AB 1986/08/25 SUN PHARM INDUSTRIES
076899 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription No No AB 2005/01/27 AMNEAL PHARMS NY
076817 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription No No AB 2005/10/07 VISTA PHARMS
078060 002 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription No No AB 2007/01/25 CHARTWELL MOLECULES
090624 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription No No AB 2010/02/16 AUROBINDO PHARMA
090828 002 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription No No AB 2010/12/22 GLENMARK GENERICS
活性成分:SULFAMETHOXAZOLE; TRIMETHOPRIM 剂型/给药途径:TABLET;ORAL 规格:800MG;160MG 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
017376 002 NDA SEPTRA DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription No No AB Approved Prior to Jan 1, 1982 MONARCH PHARMS
017377 002 NDA BACTRIM DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 SUN PHARM INDUSTRIES
071017 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription No No AB 1986/08/25 SUN PHARM INDUSTRIES
076899 002 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription No No AB 2005/01/27 AMNEAL PHARMS NY
076817 002 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription No No AB 2005/10/07 VISTA PHARMS
078060 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription No No AB 2007/01/25 CHARTWELL MOLECULES
090624 002 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription No No AB 2010/02/16 AUROBINDO PHARMA
090828 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription No No AB 2010/12/22 GLENMARK GENERICS
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