药品注册申请号:017376
申请类型:NDA (新药申请)
申请人:MONARCH PHARMS
申请人全名:MONARCH PHARMACEUTICALS 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 SEPTRA SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG No No AB 1973/07/30 Approved Prior to Jan 1, 1982 Prescription
002 SEPTRA DS SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG No No 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
2018/02/01 SUPPL 61 Approval Labeling STANDARD
2013/08/30 SUPPL 60 Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2008/03/11 SUPPL 58 Approval Labeling STANDARD
2007/09/10 SUPPL 59 Approval Labeling STANDARD
2005/07/28 SUPPL 56 Approval Labeling STANDARD
2000/10/04 SUPPL 55 Approval Manufacturing (CMC) PRIORITY
2000/01/31 SUPPL 54 Approval Manufacturing (CMC) PRIORITY
1998/04/07 SUPPL 52 Approval Labeling STANDARD
1997/03/19 SUPPL 51 Approval Labeling STANDARD
1997/03/19 SUPPL 44 Approval Labeling
1997/03/19 SUPPL 42 Approval Labeling
1997/02/12 SUPPL 53 Approval Labeling STANDARD
1996/09/11 SUPPL 48 Approval Labeling STANDARD
1994/01/07 SUPPL 47 Approval Labeling STANDARD
1993/02/22 SUPPL 46 Approval Manufacturing (CMC) PRIORITY
1992/12/01 SUPPL 45 Approval Manufacturing (CMC) PRIORITY
1990/11/09 SUPPL 39 Approval Labeling
1990/06/15 SUPPL 41 Approval Efficacy
1989/02/02 SUPPL 40 Approval Labeling
1987/08/11 SUPPL 37 Approval Labeling
1985/08/09 SUPPL 38 Approval Manufacturing (CMC) PRIORITY
1985/02/20 SUPPL 35 Approval Manufacturing (CMC) PRIORITY
1985/01/16 SUPPL 36 Approval Manufacturing (CMC) PRIORITY
1984/11/01 SUPPL 31 Approval Labeling
1983/03/25 SUPPL 33 Approval Manufacturing (CMC) PRIORITY
1982/12/07 SUPPL 32 Approval Manufacturing (CMC) PRIORITY
1982/04/27 SUPPL 30 Approval Labeling
1981/11/03 SUPPL 29 Approval Manufacturing (CMC) PRIORITY
1981/10/09 SUPPL 28 Approval Manufacturing (CMC) PRIORITY
1981/01/09 SUPPL 27 Approval Manufacturing (CMC) PRIORITY
1980/10/31 SUPPL 26 Approval Labeling
1980/10/28 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
1980/09/09 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1979/07/26 SUPPL 21 Approval Efficacy
1978/12/08 SUPPL 22 Approval Manufacturing (CMC) PRIORITY
1978/11/20 SUPPL 23 Approval Manufacturing (CMC) PRIORITY
1978/10/11 SUPPL 17 Approval Efficacy
1977/07/05 SUPPL 20 Approval Manufacturing (CMC) PRIORITY
1977/04/21 SUPPL 19 Approval Manufacturing (CMC) PRIORITY
1977/03/07 SUPPL 13 Approval Manufacturing (CMC) PRIORITY
1976/12/27 SUPPL 12 Approval Labeling
1976/11/22 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1976/11/22 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
1976/02/12 SUPPL 10 Approval Labeling
1975/05/15 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1974/11/25 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1974/10/08 SUPPL 5 Approval Labeling
1974/10/08 SUPPL 2 Approval Supplement PRIORITY
1974/05/01 SUPPL 3 Approval Supplement PRIORITY
1973/07/30 ORIG 1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY
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
070030 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG Prescription No No AB 1987/06/02 HERITAGE PHARMA
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
070037 001 ANDA SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 800MG;160MG Prescription No No AB 1987/06/02 HERITAGE PHARMA
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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