药品注册申请号:216171
申请类型:ANDA (仿制药申请)
申请人:BE PHARMS
申请人全名:BE PHARMACEUTICALS AG
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 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL No No AP 2022/05/18 2022/05/18 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
2023/09/11 SUPPL-4(补充) Approval Labeling STANDARD
2022/05/18 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
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
与本品治疗等效的药品
活性成分:PANTOPRAZOLE SODIUM 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:EQ 40MG BASE/VIAL 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
020988 001 NDA PROTONIX IV PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription Yes Yes AP 2001/03/22 WYETH PHARMS
079197 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2012/11/08 EPIC PHARMA LLC
090296 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2015/07/14 SANDOZ
205675 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2016/03/30 EUGIA PHARMA
077674 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Discontinued No No AP 2019/08/19 SUN PHARM
209524 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2021/08/30 HANGZHOU ZHONGMEI
213778 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2022/05/18 ASPIRO
204400 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2022/05/18 GLAND PHARMA LTD
216171 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2022/05/18 BE PHARMS
214680 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2022/05/19 KNACK
215860 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;INTRAVENOUS EQ 40MG BASE/VIAL Prescription No No AP 2022/08/29 MEITHEAL
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