药品注册申请号:021817
申请类型:NDA (新药申请)
申请人:SANDOZ
申请人全名:SANDOZ 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 RECLAST ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Yes Yes AP 2007/04/16 2007/04/16 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
2020/04/29 SUPPL-28(补充) Approval Labeling STANDARD
2017/07/07 SUPPL-27(补充) Approval Labeling STANDARD
2016/05/24 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
2016/04/14 SUPPL-22(补充) Approval Labeling STANDARD
2015/04/16 SUPPL-21(补充) Approval Labeling STANDARD
2015/01/30 SUPPL-20(补充) Approval Labeling STANDARD
2014/06/17 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
2014/05/13 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
2013/09/17 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
2013/07/23 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
2013/04/19 SUPPL-15(补充) Approval Labeling STANDARD
2011/08/31 SUPPL-12(补充) Approval Labeling UNKNOWN
2011/08/15 SUPPL-13(补充) Approval REMS N/A
2011/03/08 SUPPL-6(补充) Approval Labeling UNKNOWN
2011/01/25 SUPPL-9(补充) Approval REMS N/A
2009/05/29 SUPPL-4(补充) Approval Efficacy UNKNOWN
2009/03/13 SUPPL-3(补充) Approval Efficacy UNKNOWN
2008/12/19 SUPPL-2(补充) Approval Efficacy UNKNOWN
2008/06/03 SUPPL-1(补充) Approval Efficacy STANDARD
2007/04/16 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY
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 7932241 2028/02/05 Y 2011/05/25 PDF格式
7932241*PED 2028/08/05 PDF格式
001 4939130 2012/09/02 Y Y U-662 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**
8052987 2023/10/27 U-1199 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-271 2010/08/17**本条是由Drugfuture回溯的历史信息**
I-581 2011/12/19**本条是由Drugfuture回溯的历史信息**
NP 2010/04/16**本条是由Drugfuture回溯的历史信息**
PED 2010/10/16**本条是由Drugfuture回溯的历史信息**
PED 2011/02/17**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 5MG 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
021817 001 NDA RECLAST ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription Yes Yes AP 2007/04/16 SANDOZ
091363 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2013/03/29 DR REDDYS LABS LTD
202837 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2013/04/05 HOSPIRA INC
202163 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2013/08/05 CHARTWELL RX
202828 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2013/09/23 INFORLIFE
200918 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2014/08/21 EPIC PHARMA LLC
204367 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2015/12/24 APOTEX
204217 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2016/08/18 GLAND
203841 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2017/02/14 MYLAN LABS LTD
205254 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2017/10/27 MYLAN LABS LTD
209125 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Discontinued No No AP 2017/12/08 EUGIA PHARMA
209578 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2019/08/08 GLAND PHARMA LTD
213371 001 ANDA ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML Prescription No No AP 2023/06/05 MEITHEAL
更多信息
药品NDC数据与药品包装、标签说明书
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