药品注册申请号:020988
申请类型:NDA (新药申请)
申请人:WYETH PHARMS
申请人全名:WYETH PHARMACEUTICALS 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 PROTONIX IV PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Yes Yes AP;AP 2001/03/22 2001/03/22 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/04/25 SUPPL 61 Approval Labeling STANDARD
2018/06/07 SUPPL 60 Approval Labeling STANDARD
2017/12/20 SUPPL 55 Approval Labeling STANDARD
2017/12/06 SUPPL 58 Approval Labeling STANDARD
2017/07/06 SUPPL 59 Approval Labeling STANDARD
2016/10/24 SUPPL 54 Approval Labeling STANDARD
2015/11/09 SUPPL 53 Approval Manufacturing (CMC) STANDARD
2014/12/19 SUPPL 52 Approval Labeling 901 REQUIRED
2014/11/05 SUPPL 51 Approval Manufacturing (CMC) STANDARD
2014/09/26 SUPPL 50 Approval Manufacturing (CMC) STANDARD
2014/09/26 SUPPL 49 Approval Manufacturing (CMC) STANDARD
2014/03/04 SUPPL 47 Approval Manufacturing (CMC) STANDARD
2013/12/12 SUPPL 48 Approval Labeling STANDARD
2012/09/28 SUPPL 44 Approval Labeling STANDARD
2012/05/10 SUPPL 45 Approval Labeling STANDARD
2011/12/07 SUPPL 42 Approval Labeling UNKNOWN
2011/06/07 SUPPL 41 Approval Labeling UNKNOWN
2011/05/20 SUPPL 43 Approval Labeling UNKNOWN
2010/09/03 SUPPL 40 Approval Labeling UNKNOWN
2007/12/20 SUPPL 38 Approval Labeling STANDARD
2005/08/03 SUPPL 32 Approval Manufacturing (CMC) STANDARD
2005/08/02 SUPPL 31 Approval Labeling STANDARD
2004/12/06 ORIG 27 Approval Supplement STANDARD
2004/12/06 SUPPL 27 Approval Efficacy UNKNOWN
2004/11/18 SUPPL 28 Approval Labeling STANDARD
2004/10/28 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2004/05/05 SUPPL 19 Approval Labeling STANDARD
2004/04/02 SUPPL 25 Approval Labeling STANDARD
2004/04/02 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2004/03/05 SUPPL 15 Approval Labeling STANDARD
2004/01/09 SUPPL 20 Approval Labeling STANDARD
2004/01/02 SUPPL 21 Approval Labeling STANDARD
2003/11/18 SUPPL 17 Approval Labeling STANDARD
2003/10/24 SUPPL 16 Approval Labeling STANDARD
2003/02/21 SUPPL 7 Approval Labeling STANDARD
2002/12/04 SUPPL 14 Approval Manufacturing (CMC) STANDARD
2002/12/03 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2002/10/28 SUPPL 12 Approval Labeling STANDARD
2002/07/02 SUPPL 9 Approval Manufacturing (CMC) STANDARD
2002/05/14 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2002/01/18 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2002/01/15 SUPPL 1 Approval Manufacturing (CMC) STANDARD
2001/11/28 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2001/10/19 SUPPL 3 Approval Efficacy PRIORITY
2001/09/27 SUPPL 2 Approval Manufacturing (CMC) STANDARD
2001/07/03 SUPPL 4 Approval Labeling STANDARD
2001/06/08 SUPPL 6 Approval Manufacturing (CMC) STANDARD
2001/03/22 ORIG 1 Approval Type 3 - New Dosage Form 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
001 6780881 2021/11/17 Y PDF格式
6780881*PED 2022/05/17 PDF格式
7351723 2021/11/17 Y PDF格式
7351723*PED 2022/05/17 PDF格式
8754108 2021/11/17 Y PDF格式
8754108*PED 2022/05/17 PDF格式
001 4758579 2010/07/19 PDF格式**本条是由Drugfuture回溯的历史信息**
4758579*PED 2011/01/19 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 I-444 2007/12/06**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:PANTOPRAZOLE SODIUM 剂型/给药途径:INJECTABLE;IV (INFUSION) 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;IV (INFUSION) EQ 40MG BASE/VIAL Prescription Yes Yes AP 2001/03/22 WYETH PHARMS
079197 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2012/11/08 AKORN INC
090296 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2015/07/14 SANDOZ INC
205675 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2016/03/30 AUROBINDO PHARMA LTD
208580 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2018/05/04 MYLAN LABS LTD
077674 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2019/08/19 SUN PHARM
活性成分:PANTOPRAZOLE SODIUM 剂型/给药途径:INJECTABLE;IV (INFUSION) 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;IV (INFUSION) EQ 40MG BASE/VIAL Prescription Yes Yes AP 2001/03/22 WYETH PHARMS
079197 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2012/11/08 AKORN INC
090296 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2015/07/14 SANDOZ INC
205675 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2016/03/30 AUROBINDO PHARMA LTD
208580 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2018/05/04 MYLAN LABS LTD
077674 001 ANDA PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM INJECTABLE;IV (INFUSION) EQ 40MG BASE/VIAL Prescription No No AP 2019/08/19 SUN PHARM
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