药品注册申请号：210839
申请类型：ANDA (仿制药申请)
申请人：AMNEAL
申请人全名：AMNEAL EU LTD
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 NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML No No AP 2018/12/17 2018/12/17 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
2020/10/30 SUPPL-6（补充） Approval Labeling STANDARD
2018/12/17 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:NOREPINEPHRINE BITARTRATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG 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
007513 001 NDA LEVOPHED NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA
040455 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2003/03/03 MEITHEAL
040462 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2003/10/31 HIKMA
040859 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2012/03/27 BAXTER HLTHCARE CORP
211242 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2018/10/04 MYLAN LABS LTD
211359 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2018/10/18 SANDOZ
203662 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2018/11/07 HIKMA
210839 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2018/12/17 AMNEAL
211382 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2020/11/03 FRESENIUS KABI USA
214455 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2021/01/22 BRECKENRIDGE
211980 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Discontinued No No AP 2021/01/29 SUN PHARM
214323 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2021/05/06 GLAND PHARMA LTD
216341 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Discontinued No No AP 2022/07/19 ZYDUS PHARMS
217575 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2023/09/15 CAPLIN
218758 001 ANDA NOREPINEPHRINE BITARTRATE NOREPINEPHRINE BITARTRATE INJECTABLE;INJECTION EQ 1MG BASE/ML Prescription No No AP 2024/05/13 RISING
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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