药品注册申请号：079199
申请类型：ANDA (仿制药申请)
申请人：MYLAN INSTITUTIONAL
申请人全名：MYLAN INSTITUTIONAL 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 ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) No No AP 2008/11/26 2008/11/26 Prescription
002 ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) No No AP 2008/11/26 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
2019/04/16 SUPPL-10（补充） Approval Labeling STANDARD
2019/04/16 SUPPL-9（补充） Approval Labeling STANDARD
2018/07/26 SUPPL-8（补充） Approval Labeling STANDARD
2015/11/12 SUPPL-6（补充） Approval Labeling STANDARD
2012/11/21 SUPPL-5（补充） Approval Labeling STANDARD
2012/07/20 SUPPL-4（补充） Approval Labeling STANDARD
2011/05/24 SUPPL-1（补充） Approval Labeling
2008/11/26 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:ROCURONIUM BROMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/5ML (10MG/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
078519 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2008/11/26 HOSPIRA
079199 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2008/11/26 MYLAN INSTITUTIONAL
079195 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No Yes AP 2008/12/05 SANDOZ
078651 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2008/12/29 FRESENIUS KABI USA
091458 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2010/07/28 SAGENT PHARMS INC
091115 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2012/08/27 TAMARANG
204679 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2017/02/28 WEST WARD PHARM CORP
206206 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2017/04/12 EUGIA PHARMA
205656 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2018/04/04 GLAND PHARMA LTD
210437 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2019/08/13 PIRAMAL CRITICAL
212668 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2022/05/26 PRINSTON INC
216234 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2023/03/02 CAPLIN
213453 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2023/05/08 MEITHEAL
217034 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Discontinued No No AP 2023/05/24 HIKMA
215684 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2024/07/12 SHANDONG
204918 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Discontinued No No AP 2024/07/12 NORVIUM BIOSCIENCE
217092 001 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) Prescription No No AP 2024/07/22 STERISCIENCE
活性成分:ROCURONIUM BROMIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:100MG/10ML (10MG/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
078519 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2008/11/26 HOSPIRA
079199 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2008/11/26 MYLAN INSTITUTIONAL
079195 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No Yes AP 2008/12/05 SANDOZ
078651 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2008/12/29 FRESENIUS KABI USA
091458 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2010/07/28 SAGENT PHARMS INC
091115 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2012/08/27 TAMARANG
204679 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2017/02/28 WEST WARD PHARM CORP
206206 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2017/04/12 EUGIA PHARMA
205656 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2018/04/04 GLAND PHARMA LTD
210437 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2019/08/13 PIRAMAL CRITICAL
212668 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2022/05/26 PRINSTON INC
216234 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2023/03/02 CAPLIN
213453 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2023/05/08 MEITHEAL
215684 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Prescription No No AP 2024/07/12 SHANDONG
204918 002 ANDA ROCURONIUM BROMIDE ROCURONIUM BROMIDE INJECTABLE;INJECTION 100MG/10ML (10MG/ML) Discontinued No No AP 2024/07/12 NORVIUM BIOSCIENCE
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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