药品注册申请号：207350
申请类型：ANDA (仿制药申请)
申请人：HQ SPCLT PHARMA
申请人全名：HQ SPECIALTY PHARMA CORP
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 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE INJECTABLE;INJECTION 2GM/50ML (40MG/ML) No No AP 2017/12/06 2017/12/06 Prescription
002 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE INJECTABLE;INJECTION 4GM/100ML (40MG/ML) No No AP 2017/12/06 Prescription
003 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE INJECTABLE;INJECTION 4GM/50ML (80MG/ML) No No AP 2017/12/06 Prescription
004 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE INJECTABLE;INJECTION 20GM/500ML (40MG/ML) No No AP 2017/12/06 Prescription
005 MAGNESIUM SULFATE IN PLASTIC CONTAINER MAGNESIUM SULFATE INJECTABLE;INJECTION 40GM/1000ML (40MG/ML) No No AP 2017/12/06 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
2017/12/06 ORIG-1（原始申请） Approval 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: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RLDRSTE 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: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RLDRSTE 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RLDRSTE 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: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RLDRSTE 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RLDRSTE 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
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