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 |
|---|
| 2018/09/18 |
SUPPL-51（补充） |
Approval |
REMS |
|
|
|
| 2017/05/26 |
SUPPL-48（补充） |
Approval |
REMS |
|
|
|
| 2016/09/30 |
SUPPL-47（补充） |
Approval |
REMS |
|
|
|
| 2016/04/20 |
SUPPL-44（补充） |
Approval |
REMS |
|
|
|
| 2015/06/26 |
SUPPL-41（补充） |
Approval |
REMS |
|
|
|
| 2014/08/19 |
SUPPL-38（补充） |
Approval |
REMS |
|
|
|
| 2014/08/11 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/08/28 |
SUPPL-32（补充） |
Approval |
REMS |
|
|
|
| 2012/07/09 |
SUPPL-30（补充） |
Approval |
Labeling |
|
|
|
| 2012/07/09 |
SUPPL-28（补充） |
Approval |
REMS |
|
|
|
| 2010/12/20 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 2010/07/02 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 2002/11/06 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/11/06 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/11/26 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/08/15 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/01/25 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/09/15 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 2000/09/15 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/09/15 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/09/15 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 2000/09/15 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/11/03 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/08/12 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/10/28 |
ORIG-1（原始申请） |
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 |
|---|
| 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 | RLD | RS | TE 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: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 | RLD | RS | TE 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 | RLD | RS | TE 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: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 | RLD | RS | TE 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 | RLD | RS | TE 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 |
