药品注册申请号:021223
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS PHARMACEUTICALS CORP
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 ZOMETA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2001/08/20 2001/08/20 Discontinued
002 ZOMETA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Yes No AP 2003/03/07 Discontinued
003 ZOMETA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/100ML Yes No AP 2011/06/17 Discontinued
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
2018/12/14 SUPPL-41(补充) Approval Labeling STANDARD
2017/01/26 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2016/12/28 SUPPL-35(补充) Approval Labeling STANDARD
2016/11/15 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
2016/04/22 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
2016/03/29 SUPPL-34(补充) Approval Labeling STANDARD
2015/06/09 SUPPL-32(补充) Approval Labeling STANDARD
2015/01/05 SUPPL-31(补充) Approval Labeling STANDARD
2014/06/17 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
2014/04/07 SUPPL-28(补充) Approval Labeling STANDARD
2013/09/27 SUPPL-27(补充) Approval Labeling STANDARD
2013/03/06 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
2012/11/09 SUPPL-23(补充) Approval Labeling STANDARD
2012/03/14 SUPPL-22(补充) Approval Labeling UNKNOWN
2009/11/09 SUPPL-18(补充) Approval Labeling STANDARD
2008/03/20 SUPPL-16(补充) Approval Efficacy PRIORITY
2007/11/02 SUPPL-15(补充) Approval Labeling STANDARD
2007/11/02 SUPPL-14(补充) Approval Labeling STANDARD
2006/05/25 SUPPL-12(补充) Approval Labeling STANDARD
2005/10/11 SUPPL-11(补充) Approval Labeling STANDARD
2005/01/31 SUPPL-10(补充) Approval Labeling STANDARD
2005/01/31 SUPPL-9(补充) Approval Labeling STANDARD
2004/03/24 SUPPL-8(补充) Approval Labeling STANDARD
2004/02/27 SUPPL-6(补充) Approval Labeling STANDARD
2003/03/07 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
2002/05/13 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
2002/02/22 SUPPL-3(补充) Approval Labeling STANDARD
2002/02/12 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY ;Orphan
2001/08/20 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity PRIORITY ;Orphan
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
002 8324189 2025/05/29 U-1308 U-1309 U-53 2012/12/21 PDF格式
8324189*PED 2025/11/29 PDF格式
003 7932241 2028/02/05 Y 2011/06/30 PDF格式
8324189 2025/05/29 U-1308 U-1309 U-53 2012/12/21 PDF格式
8324189*PED 2025/11/29 PDF格式
001 4777163 2007/07/24 PDF格式**本条是由Drugfuture回溯的历史信息**
4939130 2012/09/02 Y Y U-53 PDF格式**本条是由Drugfuture回溯的历史信息**
4939130*PED 2013/03/02 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4777163 2007/07/24 PDF格式**本条是由Drugfuture回溯的历史信息**
4939130 2012/09/02 Y Y U-53 PDF格式**本条是由Drugfuture回溯的历史信息**
4939130*PED 2013/03/02 PDF格式**本条是由Drugfuture回溯的历史信息**
8324189 2025/05/29 U-1309 U-1308 U-53 PDF格式**本条是由Drugfuture回溯的历史信息**
003 8324189 2025/05/29 U-1308 U-53 U-1309 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 NCE 2006/08/20**本条是由Drugfuture回溯的历史信息**
ODE 2008/08/20**本条是由Drugfuture回溯的历史信息**
PED 2009/02/20**本条是由Drugfuture回溯的历史信息**
002 M-61 2011/03/20**本条是由Drugfuture回溯的历史信息**
NCE 2006/08/20**本条是由Drugfuture回溯的历史信息**
ODE 2008/08/20**本条是由Drugfuture回溯的历史信息**
PED 2009/02/20**本条是由Drugfuture回溯的历史信息**
PED 2011/09/20**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:ZOLEDRONIC ACID 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:EQ 4MG BASE/5ML 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
021223 002 NDA ZOMETA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Discontinued Yes No AP 2003/03/07 NOVARTIS
091186 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No Yes AP 2013/03/04 DR REDDYS LABS LTD
202650 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2013/03/04 MYLAN LABS LTD
201783 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2013/03/12 AVET LIFESCIENCES
202571 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2013/05/07 CHARTWELL RX
202182 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2013/06/03 HIKMA FARMACEUTICA
202930 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2013/08/05 GLAND PHARMA LTD
202548 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2014/05/22 EPIC PHARMA LLC
202923 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2014/09/04 USV
091493 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2014/11/24 SAGENT PHARMS INC
090621 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Discontinued No No AP 2015/03/19 HOSPIRA
091516 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2015/04/23 FRESENIUS KABI USA
207751 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Discontinued No No AP 2016/09/26 EUGIA PHARMA
205279 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2016/11/28 ACCORD HLTHCARE
207341 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Prescription No No AP 2017/12/29 BPI LABS
208968 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML Discontinued No No AP 2020/02/19 NOVAST LABS
活性成分:ZOLEDRONIC ACID 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:EQ 4MG BASE/100ML 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
021223 003 NDA ZOMETA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/100ML Discontinued Yes No AP 2011/06/17 NOVARTIS
203231 001 NDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/100ML Prescription Yes Yes AP 2013/08/02 INFORLIFE
210174 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/100ML Prescription No No AP 2017/10/27 AMNEAL
205749 001 ANDA ZOLEDRONIC ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/100ML Prescription No Yes AP 2018/06/29 GLAND PHARMA LTD
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