药品注册申请号：019516
申请类型：NDA (新药申请)
申请人：PURDUE PHARMA LP
申请人全名：PURDUE PHARMA LP
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 MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 30MG Yes No AB 1987/05/29 1987/05/29 Prescription
002 MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 60MG Yes No AB 1988/04/08 Prescription
003 MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 15MG Yes No AB 1989/09/12 Prescription
004 MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG Yes Yes AB 1990/01/16 Prescription
005 MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 200MG Yes No AB 1993/11/08 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-58（补充） Approval Labeling STANDARD
2021/03/04 SUPPL-57（补充） Approval Labeling STANDARD
2019/10/07 SUPPL-55（补充） Approval Labeling STANDARD
2018/09/18 SUPPL-54（补充） Approval Labeling STANDARD
2018/09/18 SUPPL-53（补充） Approval REMS N/A
2017/05/26 SUPPL-52（补充） Approval REMS N/A
2016/12/16 SUPPL-49（补充） Approval Labeling STANDARD
2016/09/30 SUPPL-50（补充） Approval REMS N/A
2016/04/20 SUPPL-47（补充） Approval REMS N/A
2015/06/26 SUPPL-46（补充） Approval REMS N/A
2014/10/22 SUPPL-43（补充） Approval Labeling STANDARD
2014/08/19 SUPPL-44（补充） Approval REMS N/A
2014/06/02 SUPPL-40（补充） Approval Manufacturing (CMC) PRIORITY
2014/04/16 SUPPL-42（补充） Approval Labeling 901 REQUIRED
2013/04/15 SUPPL-38（补充） Approval REMS N/A
2012/07/09 SUPPL-37（补充） Approval Labeling STANDARD
2012/07/09 SUPPL-36（补充） Approval REMS N/A
2010/05/11 SUPPL-34（补充） Approval Labeling UNKNOWN
2007/05/11 SUPPL-30（补充） Approval Labeling STANDARD
2003/08/06 SUPPL-21（补充） Approval Labeling STANDARD
2003/02/21 SUPPL-19（补充） Approval Manufacturing (CMC) PRIORITY
2001/12/18 SUPPL-16（补充） Approval Labeling STANDARD
2001/02/12 SUPPL-15（补充） Approval Labeling STANDARD
2000/06/27 SUPPL-13（补充） Approval Manufacturing (CMC) PRIORITY
2000/05/12 SUPPL-8（补充） Approval Manufacturing (CMC) PRIORITY
2000/05/02 SUPPL-14（补充） Approval Manufacturing (CMC) PRIORITY
2000/05/02 SUPPL-12（补充） Approval Manufacturing (CMC) PRIORITY
2000/05/02 SUPPL-11（补充） Approval Manufacturing (CMC) PRIORITY
2000/05/02 SUPPL-10（补充） Approval Manufacturing (CMC) PRIORITY
2000/05/02 SUPPL-9（补充） Approval Manufacturing (CMC) PRIORITY
1997/04/29 SUPPL-7（补充） Approval Manufacturing (CMC) PRIORITY
1993/11/08 SUPPL-4（补充） Approval Manufacturing (CMC) PRIORITY
1990/04/12 SUPPL-6（补充） Approval Manufacturing (CMC) PRIORITY
1990/01/16 SUPPL-3（补充） Approval Manufacturing (CMC) PRIORITY
1989/09/12 SUPPL-2（补充） Approval Manufacturing (CMC) PRIORITY
1988/05/02 SUPPL-5（补充） Approval Manufacturing (CMC) PRIORITY
1988/04/08 SUPPL-1（补充） Approval Manufacturing (CMC) PRIORITY
1987/05/29 ORIG-1（原始申请） Approval Type 3 - New Dosage Form PRIORITY
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: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
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 Prescription 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
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 Prescription 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
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
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 Prescription 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:100MG 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 004 NDA MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription Yes Yes AB 1990/01/16 PURDUE PHARMA LP
074769 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 1998/07/02 RHODES PHARMS
075295 004 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2000/09/15 STRIDES PHARMA
076438 001 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2003/07/03 SPECGX LLC
078761 004 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2012/05/11 SUN PHARM INDS LTD
203849 004 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2015/04/06 ACTAVIS ELIZABETH
203602 004 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2015/12/16 NOVEL LABS INC
205386 004 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 100MG 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:200MG 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 005 NDA MS CONTIN MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription Yes No AB 1993/11/08 PURDUE PHARMA LP
074769 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 1998/07/02 RHODES PHARMS
075295 005 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2000/09/15 STRIDES PHARMA
076438 002 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2003/07/03 SPECGX LLC
078761 005 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2012/05/11 SUN PHARM INDS LTD
203849 005 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2015/04/06 ACTAVIS ELIZABETH
203602 005 ANDA MORPHINE SULFATE MORPHINE SULFATE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2015/12/16 NOVEL LABS INC
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database