药品注册申请号：212171
申请类型：ANDA (仿制药申请)
申请人：ZYDUS PHARMS
申请人全名：ZYDUS PHARMACEUTICALS USA INC
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 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML No No AP 2019/11/04 2019/11/04 Prescription
002 CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML No No AP 2019/11/04 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
2023/08/29 SUPPL-5（补充） Approval Labeling STANDARD
2019/11/04 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:CISATRACURIUM BESYLATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2MG BASE/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
020551 001 NDA NIMBEX CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Discontinued Yes No AP 1995/12/15 ABBVIE
020551 003 NDA NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Discontinued Yes No AP 1995/12/15 ABBVIE
200154 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2012/02/03 SANDOZ INC
200159 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2012/02/03 SANDOZ INC
203182 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2015/02/26 FRESENIUS KABI USA
203183 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2015/02/26 FRESENIUS KABI USA
204960 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2017/01/27 HENGRUI PHARMA
209334 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2017/08/30 HENGRUI PHARMA
203236 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2018/03/30 HOSPIRA
203238 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2018/03/30 HOSPIRA
206791 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/02/20 SOMERSET THERAPS LLC
209132 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/04/24 SOMERSET
211668 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No Yes AP 2019/04/25 MEITHEAL
211669 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No Yes AP 2019/04/25 MEITHEAL
212171 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2019/11/04 ZYDUS PHARMS
209144 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2020/05/08 EUGIA PHARMA
209665 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2020/10/27 EUGIA PHARMA
201836 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2020/11/06 SAGENT PHARMS INC
201851 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2020/11/06 SAGENT PHARMS INC
212432 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Discontinued No No AP 2022/03/11 PIRAMAL
215516 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2022/05/24 PIRAMAL CRITICAL
203078 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2022/06/28 HIKMA
215516 003 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2022/12/14 PIRAMAL CRITICAL
203079 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2023/04/19 HIKMA
217725 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Discontinued No No AP 2023/06/09 CAPLIN
216538 001 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2024/03/08 HAINAN POLY
216539 001 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 2MG BASE/ML Prescription No No AP 2024/08/27 HAINAN POLY
活性成分:CISATRACURIUM BESYLATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 10MG BASE/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
020551 002 NDA NIMBEX PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Discontinued Yes No AP 1995/12/15 ABBVIE
200154 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2012/02/03 SANDOZ INC
203182 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2015/02/26 FRESENIUS KABI USA
204960 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2017/09/19 HENGRUI PHARMA
203236 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2018/03/30 HOSPIRA
206791 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2019/02/20 SOMERSET THERAPS LLC
211668 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No Yes AP 2019/04/25 MEITHEAL
212171 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2019/11/04 ZYDUS PHARMS
201836 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2020/11/06 SAGENT PHARMS INC
212432 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Discontinued No No AP 2022/03/11 PIRAMAL
215516 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2022/05/24 PIRAMAL CRITICAL
217725 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Discontinued No No AP 2023/06/09 CAPLIN
203078 002 ANDA CISATRACURIUM BESYLATE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2023/12/18 HIKMA
216539 002 ANDA CISATRACURIUM BESYLATE PRESERVATIVE FREE CISATRACURIUM BESYLATE INJECTABLE;INJECTION EQ 10MG BASE/ML Prescription No No AP 2024/08/27 HAINAN POLY
更多信息
药品NDC数据与药品包装、标签说明书
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