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 |
|---|
| 1988/03/24 |
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 |
|---|
| 2023/05/16 |
SUPPL-24（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2023/05/16 |
SUPPL-22（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2015/07/31 |
SUPPL-19（补充） |
Approval |
Labeling-Package Insert,Labeling-Container/Carton Labels |
STANDARD
|
|
|
| 2013/10/30 |
SUPPL-17（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2008/06/04 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 2002/07/18 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 2002/07/18 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
| 1998/01/14 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/06/10 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 1995/09/19 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/02/06 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1994/06/17 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/10/29 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/05/20 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1988/04/22 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
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:NALOXONE HYDROCHLORIDE; 剂型/给药途径:INJECTABLE;INJECTION; 规格:1MG/ML; 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 |
|---|
| 072076 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
Yes |
AP |
1988/03/24
|
INTL MEDICATION |
| 213209 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2020/03/16
|
DR REDDYS |
| 213279 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2021/01/14
|
EUGIA PHARMA |
| 213843 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2022/06/09
|
MYLAN LABS LTD |
| 212300 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2022/06/10
|
HIKMA |
| 215964 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2022/07/29
|
PH HEALTH |
| 216624 |
002 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2022/10/26
|
ACCORD HLTHCARE |
| 216977 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2023/10/06
|
BPI LABS |
| 213573 |
002 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2024/04/02
|
FRESENIUS KABI USA |
| 214785 |
002 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2025/06/03
|
BAXTER HLTHCARE CORP |