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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2017/02/14 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2025/02/03 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2025/02/03 |
SUPPL-2（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
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 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 | RLD | RS | TE 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 |
Discontinued |
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 |
| 213371 |
001 |
ANDA |
ZOLEDRONIC ACID |
ZOLEDRONIC ACID |
INJECTABLE;INTRAVENOUS |
EQ 5MG BASE/100ML |
Prescription |
No |
No |
AP |
2023/06/05
|
MEITHEAL |