药品注册申请号：076412
申请类型：ANDA (仿制药申请)
申请人：SPECGX LLC
申请人全名：SPECGX LLC
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 TABLET, EXTENDED RELEASE;ORAL 15MG No No AB 2003/07/31 2003/07/31 Prescription
002 MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG No No AB 2003/07/31 Prescription
003 MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG No No AB 2003/07/31 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2003/07/31 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2024/10/31 SUPPL-43（补充） Approval REMS-Modified
2018/09/18 SUPPL-28（补充） Approval REMS - MODIFIED - D-N-A
2017/05/26 SUPPL-26（补充） Approval REMS-Modified
2016/11/03 SUPPL-24（补充） Approval Labeling-Package Insert STANDARD
2016/09/30 SUPPL-25（补充） Approval REMS - MODIFIED - D-N-A
2016/04/20 SUPPL-22（补充） Approval REMS-Modified
2015/06/26 SUPPL-20（补充） Approval REMS-Modified
2015/05/16 SUPPL-19（补充） Approval Labeling-Container/Carton Labels STANDARD
2014/08/19 SUPPL-18（补充） Approval REMS-Modified
2014/08/13 SUPPL-11（补充） Approval Labeling-Package Insert
2014/06/25 SUPPL-15（补充） Approval Labeling-Package Insert STANDARD
2013/04/15 SUPPL-14（补充） Approval REMS-Modified
2012/07/09 SUPPL-13（补充） Approval Labeling-Package Insert
2012/07/09 SUPPL-12（补充） Approval REMS-Proposal
2009/07/22 SUPPL-10（补充） Approval Labeling
2004/09/30 SUPPL-5（补充） Approval Labeling
2004/03/19 SUPPL-2（补充） Approval Labeling
2003/11/06 SUPPL-3（补充） Approval Labeling
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
无
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
无
与本品治疗等效的药品
>>>活性成分:MORPHINE SULFATE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:15MG; 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
019516 003 NDA MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription Yes No AB 1989/09/12 PURDUE PHARMA LP
074862 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 1998/07/07 RHODES PHARMS
075295 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 1998/10/28 STRIDES PHARMA INTL
075407 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2000/01/28 DAVA PHARMS INC
076412 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2003/07/31 SPECGX LLC
078761 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2012/05/11 SUN PHARM INDS LTD
203849 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2015/04/06 ACTAVIS ELIZABETH
203602 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Discontinued No No AB 2015/12/16 NOVEL LABS INC
205386 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Discontinued No No AB 2016/10/28 DR REDDYS LABS SA
>>>活性成分:MORPHINE SULFATE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:30MG; 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
019516 001 NDA MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription Yes No AB 1987/05/29 PURDUE PHARMA LP
074862 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 1998/07/07 RHODES PHARMS
075295 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 1998/10/28 STRIDES PHARMA INTL
076412 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2003/07/31 SPECGX LLC
078761 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2012/05/11 SUN PHARM INDS LTD
203849 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2015/04/06 ACTAVIS ELIZABETH
203602 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Discontinued No No AB 2015/12/16 NOVEL LABS INC
205386 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Discontinued No No AB 2016/10/28 DR REDDYS LABS SA
>>>活性成分:MORPHINE SULFATE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:60MG; 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
019516 002 NDA MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription Yes No AB 1988/04/08 PURDUE PHARMA LP
074862 003 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 1998/07/07 RHODES PHARMS
075295 003 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 1998/10/28 STRIDES PHARMA INTL
076412 003 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2003/07/31 SPECGX LLC
078761 003 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2012/05/11 SUN PHARM INDS LTD
203849 003 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2015/04/06 ACTAVIS ELIZABETH
203602 003 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Discontinued No No AB 2015/12/16 NOVEL LABS INC
205386 003 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Discontinued No No AB 2016/10/28 DR REDDYS LABS SA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2025 DrugFuture->U.S. FDA Drugs Database