药品注册申请号:205758
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS USA 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 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 4MG/ML No Yes AP 2015/05/21 2015/05/21 Prescription
002 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 8MG/ML No Yes AP 2015/05/21 Prescription
003 MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML No No AP 2015/05/21 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2015/05/21 ORIG-1(原始申请) Approval 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:MORPHINE SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:4MG/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
202515 002 NDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 4MG/ML Prescription Yes No AP 2011/11/14 HOSPIRA INC
205758 001 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 4MG/ML Prescription No Yes AP 2015/05/21 HIKMA
211452 002 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 4MG/ML Prescription No No AP 2023/01/12 HIKMA
活性成分:MORPHINE SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:8MG/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
202515 003 NDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 8MG/ML Prescription Yes No AP 2011/11/14 HOSPIRA INC
205758 002 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 8MG/ML Prescription No Yes AP 2015/05/21 HIKMA
211452 003 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 8MG/ML Prescription No No AP 2023/01/12 HIKMA
活性成分:MORPHINE SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/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
018565 003 NDA INFUMORPH MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML Prescription Yes Yes AP 1991/07/19 HIKMA
202515 004 NDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML Prescription Yes No AP 2011/11/14 HOSPIRA INC
205758 003 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2015/05/21 HIKMA
204393 001 ANDA MITIGO MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2018/07/16 PIRAMAL CRITICAL
211452 004 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML Prescription No No AP 2023/01/12 HIKMA
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database