药品注册申请号:075045
申请类型:ANDA (仿制药申请)
申请人:WEST-WARD PHARMS INT
申请人全名:WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
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 No AP 1998/08/12 1998/08/12 Prescription
002 BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE INJECTABLE;INJECTION 2MG/ML No No AP 1998/08/12 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 15 Approval Labeling STANDARD
2001/10/30 SUPPL 3 Approval Labeling
2001/04/03 SUPPL 2 Approval Manufacturing (CMC)
1999/10/15 SUPPL 1 Approval Labeling
1998/08/12 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
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2020 DrugFuture->U.S. FDA Drugs Database