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 |
|---|
| 2024/09/11 |
ORIG-1（原始申请） |
Approval |
|
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:AMIODARONE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/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 |
|---|
| 075761 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
Yes |
AP |
2002/10/15
|
FRESENIUS KABI USA |
| 076217 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
Yes |
AP |
2002/10/15
|
MYLAN INSTITUTIONAL |
| 077161 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
Yes |
AP |
2005/04/20
|
GLAND PHARMA LTD |
| 077234 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2008/02/25
|
HIKMA FARMACEUTICA |
| 077610 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2008/10/30
|
ACELLA |
| 077834 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2008/10/30
|
ACELLA |
| 203884 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Discontinued |
No |
No |
AP |
2013/11/25
|
HOSPIRA |
| 204550 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Discontinued |
No |
No |
AP |
2017/10/25
|
EUGIA PHARMA |
| 218253 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2024/09/11
|
ZHEJIANG POLY PHARM |