药品注册申请号:070030
申请类型:ANDA (仿制药申请)
申请人:HERITAGE PHARMA
申请人全名:HERITAGE PHARMA LABS 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 SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH SULFAMETHOXAZOLE; TRIMETHOPRIM TABLET;ORAL 400MG;80MG No No AB 1985/09/19 1987/06/02 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
2015/01/15 SUPPL 39 Approval Labeling STANDARD
2012/12/05 SUPPL 38 Approval Labeling STANDARD
2010/09/28 SUPPL 36 Approval Labeling
2007/11/01 SUPPL 35 Approval Labeling
2005/06/21 SUPPL 34 Approval Labeling
2001/11/09 SUPPL 29 Approval Labeling
2000/08/25 SUPPL 27 Approval Labeling
2000/03/20 SUPPL 25 Approval Manufacturing (CMC)
2000/03/20 SUPPL 24 Approval Manufacturing (CMC)
1999/03/18 SUPPL 17 Approval Manufacturing (CMC)
1999/03/18 SUPPL 16 Approval Manufacturing (CMC)
1998/04/21 SUPPL 15 Approval Labeling
1997/07/24 SUPPL 12 Approval Manufacturing (CMC)
1997/04/24 SUPPL 14 Approval Manufacturing (CMC)
1997/01/14 SUPPL 13 Approval Manufacturing (CMC)
1996/05/10 SUPPL 10 Approval Labeling
1995/02/08 SUPPL 7 Approval Manufacturing (CMC)
1994/05/20 SUPPL 8 Approval Labeling
1992/01/31 SUPPL 6 Approval Labeling
1991/04/22 SUPPL 5 Approval Labeling
1991/02/23 SUPPL 4 Approval Labeling
1990/06/21 SUPPL 3 Approval Labeling
1989/03/08 SUPPL 2 Approval Labeling
1985/09/19 ORIG 1 Approval
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
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