美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=ZOLEDRONIC"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
ZOLEDRONIC ACID 202163 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML No No 2013/08/05 2013/08/05 CHARTWELL RX Prescription
ZOLEDRONIC ACID 202930 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No 2013/08/05 2013/08/05 GLAND PHARMA LTD Prescription
ZOLEDRONIC ACID 202828 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML No No 2013/09/23 2013/09/23 INFORLIFE Prescription
ZOLEDRONIC ACID 202548 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No 2014/05/22 2014/05/22 EPIC PHARMA LLC Prescription
ZOLEDRONIC ACID 078475 001 ANDA ZOLEDRONIC ACID INJECTABLE;INJECTION 4MG/5ML(0.8MG/ML) No No 2014/05/29 (TA) -- CIPLA LTD None (Tentative Approval)
ZOLEDRONIC ACID 204051 001 ANDA ZOLEDRONIC ACID INJECTABLE;INJECTION 4MG/100ML No No 2014/07/03 (TA) -- SUN PHARMA GLOBAL None (Tentative Approval)
ZOLEDRONIC ACID 204138 001 ANDA ZOLEDRONIC ACID INJECTABLE;INJECTION 5MG/100ML No No 2014/07/22 (TA) -- SUN PHARMA GLOBAL None (Tentative Approval)
ZOLEDRONIC ACID 200918 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML No No 2014/08/21 2014/08/21 EPIC PHARMA LLC Prescription
ZOLEDRONIC ACID 202923 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No 2014/09/04 2014/09/04 USV Prescription
ZOLEDRONIC ACID 091493 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No 2014/11/24 2014/11/24 SAGENT PHARMS INC Prescription
ZOLEDRONIC ACID 090621 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No 2015/03/19 2015/03/19 HOSPIRA Discontinued
ZOLEDRONIC ACID 091516 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No 2015/04/23 2015/04/23 FRESENIUS KABI USA Prescription
ZOLEDRONIC ACID 204367 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML No No 2015/12/24 2015/12/24 APOTEX Prescription
ZOLEDRONIC ACID 204016 001 NDA ZOLEDRONIC ACID SOLUTION;INTRAVENOUS EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) No No 2015/12/28 2015/12/28 HOSPIRA Prescription
ZOLEDRONIC ACID 203344 001 ANDA ZOLEDRONIC ACID INJECTABLE;INJECTION 4MG/5ML No No 2016/02/09 (TA) -- PFIZER INC None (Tentative Approval)
ZOLEDRONIC ACID 204217 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML No No 2016/08/18 2016/08/18 GLAND Prescription
ZOLEDRONIC ACID 207751 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No 2016/09/26 2016/09/26 EUGIA PHARMA Discontinued
ZOLEDRONIC ACID 205279 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 4MG BASE/5ML No No 2016/11/28 2016/11/28 ACCORD HLTHCARE Prescription
ZOLEDRONIC ACID 203841 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML No No 2017/02/14 2017/02/14 MYLAN LABS LTD Prescription
ZOLEDRONIC ACID 205254 001 ANDA ZOLEDRONIC ACID INJECTABLE;INTRAVENOUS EQ 5MG BASE/100ML No No 2017/10/27 2017/10/27 MYLAN LABS LTD Prescription
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