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 |
2022/07/28 |
SUPPL-32(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2014/11/26 |
SUPPL-30(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/11/07 |
SUPPL-20(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2013/05/29 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/01/26 |
SUPPL-15(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2002/11/06 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1998/10/28 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1998/10/22 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/07/14 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1997/04/21 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1996/08/29 |
SUPPL-3(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/08/27 |
SUPPL-2(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1996/03/28 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1995/10/23 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1995/01/18 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
1994/06/24 |
ORIG-1(原始申请) |
Approval |
Type 5 - New Formulation or New Manufacturer |
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 |
无 |
与本品治疗等效的药品
活性成分:MAGNESIUM SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:4GM/100ML (40MG/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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020309 |
001 |
NDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
Yes |
Yes |
AP |
1994/06/24
|
HOSPIRA |
206485 |
001 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
No |
No |
AP |
2016/03/15
|
FRESENIUS KABI USA |
207350 |
002 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
HQ SPCLT PHARMA |
209911 |
002 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
No |
No |
AP |
2018/09/14
|
MYLAN LABS LTD |
211966 |
003 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
No |
No |
AP |
2020/06/01
|
BAXTER HLTHCARE CORP |
213917 |
002 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
No |
No |
AP |
2020/07/10
|
GLAND PHARMA LTD |
207967 |
002 |
ANDA |
MAGNESIUM SULFATE |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
No |
No |
AP |
2021/04/26
|
B BRAUN MEDICAL INC |
209642 |
002 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
No |
No |
AP |
2021/11/08
|
MILLA PHARMS |
216597 |
002 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/100ML (40MG/ML) |
Prescription |
No |
No |
AP |
2023/02/15
|
AMNEAL |
活性成分:MAGNESIUM SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:4GM/50ML (80MG/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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020309 |
002 |
NDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/50ML (80MG/ML) |
Prescription |
Yes |
Yes |
AP |
1994/06/24
|
HOSPIRA |
206485 |
002 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/50ML (80MG/ML) |
Prescription |
No |
No |
AP |
2016/03/15
|
FRESENIUS KABI USA |
207350 |
003 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/50ML (80MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
HQ SPCLT PHARMA |
211966 |
002 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/50ML (80MG/ML) |
Prescription |
No |
No |
AP |
2020/06/01
|
BAXTER HLTHCARE CORP |
207967 |
003 |
ANDA |
MAGNESIUM SULFATE |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/50ML (80MG/ML) |
Prescription |
No |
No |
AP |
2021/04/26
|
B BRAUN MEDICAL INC |
209642 |
003 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
4GM/50ML (80MG/ML) |
Prescription |
No |
No |
AP |
2021/11/08
|
MILLA PHARMS |
活性成分:MAGNESIUM SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/50ML (40MG/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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020309 |
003 |
NDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
Yes |
No |
AP |
2007/01/26
|
HOSPIRA |
206485 |
003 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
No |
No |
AP |
2016/03/15
|
FRESENIUS KABI USA |
207350 |
001 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
HQ SPCLT PHARMA |
209911 |
001 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
No |
No |
AP |
2018/09/14
|
MYLAN LABS LTD |
211966 |
001 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
No |
No |
AP |
2020/06/01
|
BAXTER HLTHCARE CORP |
213917 |
001 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
No |
No |
AP |
2020/07/10
|
GLAND PHARMA LTD |
207967 |
001 |
ANDA |
MAGNESIUM SULFATE |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
No |
No |
AP |
2021/04/26
|
B BRAUN MEDICAL INC |
209642 |
001 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
No |
No |
AP |
2021/11/08
|
MILLA PHARMS |
216597 |
001 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
2GM/50ML (40MG/ML) |
Prescription |
No |
No |
AP |
2023/02/15
|
AMNEAL |
活性成分:MAGNESIUM SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:20GM/500ML (40MG/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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020309 |
004 |
NDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
20GM/500ML (40MG/ML) |
Prescription |
Yes |
No |
AP |
1995/01/18
|
HOSPIRA |
206485 |
004 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
20GM/500ML (40MG/ML) |
Prescription |
No |
No |
AP |
2016/03/15
|
FRESENIUS KABI USA |
207350 |
004 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
20GM/500ML (40MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
HQ SPCLT PHARMA |
活性成分:MAGNESIUM SULFATE 剂型/给药途径:INJECTABLE;INJECTION 规格:40GM/1000ML (40MG/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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
020309 |
005 |
NDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
40GM/1000ML (40MG/ML) |
Prescription |
Yes |
No |
AP |
1995/01/18
|
HOSPIRA |
206485 |
005 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
40GM/1000ML (40MG/ML) |
Prescription |
No |
No |
AP |
2016/03/15
|
FRESENIUS KABI USA |
207350 |
005 |
ANDA |
MAGNESIUM SULFATE IN PLASTIC CONTAINER |
MAGNESIUM SULFATE |
INJECTABLE;INJECTION |
40GM/1000ML (40MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
HQ SPCLT PHARMA |