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 |
|---|
| 2023/11/08 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2016/07/13 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/10/19 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/05/27 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/01/02 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/01/02 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/01/02 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/08/05 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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 |
|---|
| 无 |
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 | RLD | RS | TE 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 |