药品注册申请号:074626
申请类型:ANDA (仿制药申请)
申请人:HOSPIRA
申请人全名:HOSPIRA 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 BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML No Yes AP 1997/01/23 1997/01/23 Prescription
002 BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No Yes AP 1997/01/23 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
2019/10/11 SUPPL 30 Approval Labeling STANDARD
2016/12/16 SUPPL 28 Approval Labeling STANDARD
2016/12/16 SUPPL 27 Approval Labeling STANDARD
2003/05/08 SUPPL 13 Approval Labeling
2002/10/25 SUPPL 14 Approval Manufacturing (CMC)
2002/09/18 SUPPL 15 Approval Labeling
2001/09/07 SUPPL 12 Approval Manufacturing (CMC)
2001/03/22 SUPPL 10 Approval Manufacturing (CMC)
2001/03/22 SUPPL 9 Approval Manufacturing (CMC)
2001/02/14 SUPPL 11 Approval Manufacturing (CMC)
2000/03/01 SUPPL 8 Approval Manufacturing (CMC)
2000/03/01 SUPPL 6 Approval Manufacturing (CMC)
2000/03/01 SUPPL 5 Approval Labeling
2000/03/01 SUPPL 4 Approval Manufacturing (CMC)
2000/01/07 SUPPL 3 Approval Labeling
2000/01/07 SUPPL 2 Approval Manufacturing (CMC)
1999/10/22 SUPPL 7 Approval Labeling
1998/11/23 SUPPL 1 Approval Manufacturing (CMC)
1997/01/23 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:BUTORPHANOL TARTRATE 剂型/给药途径:INJECTABLE;INJECTION 规格:1MG/ML 治疗等效代码:AP
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
074626 001 ANDA BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML Prescription No Yes AP 1997/01/23 HOSPIRA
075045 001 ANDA BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 1998/08/12 WEST-WARD PHARMS INT
078400 001 ANDA BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 2009/05/01 HIKMA FARMACEUTICA
活性成分:BUTORPHANOL TARTRATE 剂型/给药途径:INJECTABLE;INJECTION 规格:2MG/ML 治疗等效代码:AP
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
074626 002 ANDA BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML Prescription No Yes AP 1997/01/23 HOSPIRA
075045 002 ANDA BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 1998/08/12 WEST-WARD PHARMS INT
075046 001 ANDA BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 1998/08/12 WEST-WARD PHARMS INT
078400 002 ANDA BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML Prescription No No AP 2009/05/01 HIKMA FARMACEUTICA
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