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 |
|---|
| 2024/01/19 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/04 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/02/08 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/02/08 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/02/08 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-6（补充） |
Approval |
REMS |
|
|
|
| 2015/08/25 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/09/27 |
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:OXYMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 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 |
|---|
| 090964 |
001 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2010/09/27
|
HIKMA |
| 091443 |
002 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/02/15
|
TEVA |
| 203601 |
001 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2013/01/30
|
AVANTHI INC |
| 202321 |
001 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Discontinued |
No |
No |
AB |
2013/04/25
|
SPECGX LLC |
| 201187 |
001 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2014/12/15
|
EPIC PHARMA LLC |
| 204459 |
001 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2016/04/26
|
AUROLIFE PHARMA LLC |
| 210175 |
001 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2018/02/02
|
ASCENT PHARMS INC |
活性成分:OXYMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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 |
|---|
| 090964 |
002 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2010/09/27
|
HIKMA |
| 091443 |
001 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2011/02/15
|
TEVA |
| 203601 |
002 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
Yes |
AB |
2013/01/30
|
AVANTHI INC |
| 202321 |
002 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
2013/04/25
|
SPECGX LLC |
| 201187 |
002 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2014/12/15
|
EPIC PHARMA LLC |
| 204459 |
002 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2016/04/26
|
AUROLIFE PHARMA LLC |
| 210175 |
002 |
ANDA |
OXYMORPHONE HYDROCHLORIDE |
OXYMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/02/02
|
ASCENT PHARMS INC |