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 |
|---|
| 2019/11/21 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/02/21 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 2007/04/12 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 2007/03/07 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 2005/05/03 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2002/08/28 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 2002/08/23 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/01/25 |
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:AMIODARONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:200MG 治疗等效代码:AB
| 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 |
|---|
| 075135 |
001 |
ANDA |
PACERONE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
1998/04/30
|
UPSHER SMITH LABS |
| 074739 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
1998/11/30
|
TEVA PHARMS |
| 075315 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Discontinued |
No |
No |
AB |
1998/12/23
|
UPSHER SMITH LABS |
| 075389 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2001/01/25
|
DR REDDYS LABS SA |
| 075424 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
Yes |
AB |
2001/03/30
|
TARO |
| 077069 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2005/04/08
|
CHARTWELL RX |
| 079029 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2008/09/16
|
ZYDUS PHARMS USA INC |
| 078578 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2008/11/06
|
RUBICON |
| 204742 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2016/06/03
|
AUROBINDO PHARMA LTD |
| 213446 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2020/07/21
|
UNICHEM |
活性成分:AMIODARONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 治疗等效代码:AB
| 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 |
|---|
| 075424 |
002 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2002/12/18
|
TARO |
| 075135 |
002 |
ANDA |
PACERONE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2005/04/12
|
UPSHER SMITH LABS |
| 077069 |
003 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2016/10/04
|
CHARTWELL RX |
| 075389 |
002 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/12/28
|
DR REDDYS LABS SA |
| 078578 |
002 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/02/26
|
RUBICON |
| 079029 |
002 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/01/06
|
ZYDUS PHARMS USA INC |
活性成分:AMIODARONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:400MG 治疗等效代码:AB
| 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 |
|---|
| 075315 |
002 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Discontinued |
No |
No |
AB |
2000/06/30
|
UPSHER SMITH LABS |
| 076362 |
001 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2002/11/29
|
TARO |
| 077069 |
002 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2005/04/08
|
CHARTWELL RX |
| 075389 |
003 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2017/12/28
|
DR REDDYS LABS SA |
| 075135 |
003 |
ANDA |
PACERONE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2020/07/02
|
UPSHER SMITH LABS |
| 078578 |
003 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2021/02/26
|
RUBICON |
| 079029 |
003 |
ANDA |
AMIODARONE HYDROCHLORIDE |
AMIODARONE HYDROCHLORIDE |
TABLET;ORAL |
400MG |
Prescription |
No |
No |
AB |
2023/01/06
|
ZYDUS PHARMS USA INC |
