药品注册申请号:018565
申请类型:NDA (新药申请)
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 DURAMORPH PF MORPHINE SULFATE INJECTABLE;INJECTION 0.5MG/ML Yes Yes AP 1984/09/18 1984/09/18 Prescription
002 DURAMORPH PF MORPHINE SULFATE INJECTABLE;INJECTION 1MG/ML Yes Yes AP 1984/09/18 Prescription
003 INFUMORPH MORPHINE SULFATE INJECTABLE;INJECTION 10MG/ML Yes Yes AP 1991/07/19 Prescription
004 INFUMORPH MORPHINE SULFATE INJECTABLE;INJECTION 25MG/ML Yes Yes AP 1991/07/19 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
2023/12/15 SUPPL-31(补充) Approval Labeling STANDARD
2023/12/15 SUPPL-30(补充) Approval Labeling STANDARD
2023/12/15 SUPPL-28(补充) Approval Labeling STANDARD
2023/12/15 SUPPL-27(补充) Approval Labeling STANDARD
2023/11/08 SUPPL-29(补充) Approval Labeling STANDARD
2019/10/07 SUPPL-24(补充) Approval Labeling STANDARD
2016/12/16 SUPPL-22(补充) Approval Labeling STANDARD DURAMORPH & INFUMORPH have separate letters and labels
2016/06/06 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
2010/10/01 SUPPL-20(补充) Approval Labeling STANDARD Label for DURAMORPH
2005/06/06 SUPPL-14(补充) Approval Labeling STANDARD Label for DURAMORPH
2004/05/27 SUPPL-12(补充) Approval Labeling STANDARD Label for INFUMORPH
2003/06/26 SUPPL-10(补充) Approval Labeling STANDARD
2001/12/07 SUPPL-9(补充) Approval Labeling STANDARD
1999/06/14 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1998/04/17 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1997/02/12 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1994/04/28 SUPPL-5(补充) Approval Labeling
1991/07/19 SUPPL-3(补充) Approval Labeling
1991/07/19 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1989/05/03 SUPPL-4(补充) Approval Labeling
1985/08/22 SUPPL-1(补充) Approval Labeling ;Orphan
1984/09/18 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY ;Orphan
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:0.5MG/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 001 NDA DURAMORPH PF MORPHINE SULFATE INJECTABLE;INJECTION 0.5MG/ML Prescription Yes Yes AP 1984/09/18 HIKMA
071849 001 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 0.5MG/ML Prescription No No AP 1988/05/11 HOSPIRA
073509 001 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 0.5MG/ML Prescription No No AP 1992/09/30 HOSPIRA
活性成分:MORPHINE SULFATE 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
018565 002 NDA DURAMORPH PF MORPHINE SULFATE INJECTABLE;INJECTION 1MG/ML Prescription Yes Yes AP 1984/09/18 HIKMA
073510 001 ANDA MORPHINE SULFATE MORPHINE SULFATE INJECTABLE;INJECTION 1MG/ML Prescription No No AP 1992/09/30 HOSPIRA
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
活性成分:MORPHINE SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:25MG/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 004 NDA INFUMORPH MORPHINE SULFATE INJECTABLE;INJECTION 25MG/ML Prescription Yes Yes AP 1991/07/19 HIKMA
204393 002 ANDA MITIGO MORPHINE SULFATE INJECTABLE;INJECTION 25MG/ML Prescription No No AP 2018/07/16 PIRAMAL CRITICAL
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