药品注册申请号:201783
申请类型:ANDA (仿制药申请)
申请人:AVET LIFESCIENCES
申请人全名:AVET LIFESCIENCES 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 ZOLEDRONIC ACID ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No AP 2013/03/12 2013/03/12 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
2016/07/14 SUPPL-11(补充) Approval Labeling STANDARD
2015/11/09 SUPPL-9(补充) Approval Labeling STANDARD
2015/03/31 SUPPL-7(补充) Approval Labeling STANDARD
2015/03/31 SUPPL-4(补充) Approval Labeling STANDARD
2015/03/31 SUPPL-3(补充) Approval Labeling STANDARD
2013/03/12 ORIG-1(原始申请) Approval Not Applicable
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: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 Prescription 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
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药品NDC数据与药品包装、标签说明书
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