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 |
|---|
| 2024/08/13 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2006/12/13 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 1997/08/08 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/04/27 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1991/07/11 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/07/31 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1987/01/07 |
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:NALOXONE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.4MG/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 |
|---|
| 070299 |
001 |
ANDA |
NALOXONE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
1986/09/24
|
HIKMA |
| 070172 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
Yes |
AP |
1986/09/24
|
HOSPIRA |
| 070256 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
Yes |
AP |
1987/01/07
|
HOSPIRA |
| 070257 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
Yes |
AP |
1987/01/07
|
HOSPIRA |
| 204997 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2014/03/06
|
MYLAN INSTITUTIONAL |
| 205014 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2016/06/29
|
MYLAN INSTITUTIONAL |
| 208871 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2017/02/28
|
RISING |
| 208872 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2017/03/14
|
RISING |
| 207634 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2017/07/26
|
SOMERSET THERAPS LLC |
| 207633 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2017/08/08
|
SOMERSET THERAPS LLC |
| 212455 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Discontinued |
No |
No |
AP |
2019/10/15
|
EUGIA PHARMA |
| 212456 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2019/11/04
|
EUGIA PHARMA |
| 214785 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2021/01/29
|
BAXTER HLTHCARE CORP |
| 216624 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2022/10/26
|
ACCORD HLTHCARE |
| 214792 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2022/11/07
|
BAXTER HLTHCARE CORP |
| 218404 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2024/02/29
|
MANKIND PHARMA |
| 212300 |
002 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2024/03/07
|
HIKMA |
| 213573 |
001 |
ANDA |
NALOXONE HYDROCHLORIDE |
NALOXONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.4MG/ML |
Prescription |
No |
No |
AP |
2024/04/02
|
FRESENIUS KABI USA |