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 |
|---|
| 2023/12/15 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/04 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/07 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-8（补充） |
Approval |
REMS |
N/A
|
|
|
| 2016/12/16 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2009/05/15 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
| 2009/02/20 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/08/31 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
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:OXYCODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:15MG 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 |
|---|
| 021011 |
001 |
NDA |
ROXICODONE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
Yes |
Yes |
AB |
2000/08/31
|
SPECGX LLC |
| 076758 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2004/06/30
|
SPECGX LLC |
| 090659 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2009/04/10
|
SUN PHARM INDS INC |
| 090895 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2009/08/24
|
EPIC PHARMA LLC |
| 091393 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2009/08/31
|
AVANTHI INC |
| 091490 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2011/03/09
|
RHODES PHARMS |
| 202116 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2011/12/30
|
ALVOGEN |
| 202160 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2012/11/19
|
AUROLIFE PHARMA LLC |
| 203638 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2014/06/03
|
AMNEAL PHARMS |
| 202662 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2015/09/22
|
EPIC PHARMA LLC |
| 207119 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2016/04/12
|
NUVO PHARM |
| 204021 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2017/06/12
|
NOVEL LABS INC |
| 207418 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
15MG |
Prescription |
No |
No |
AB |
2017/08/07
|
ASCENT PHARMS INC |
活性成分:OXYCODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:30MG 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 |
|---|
| 021011 |
002 |
NDA |
ROXICODONE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
Yes |
No |
AB |
2000/08/31
|
SPECGX LLC |
| 076758 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2004/06/30
|
SPECGX LLC |
| 090659 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2009/04/10
|
SUN PHARM INDS INC |
| 090895 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2009/08/24
|
EPIC PHARMA LLC |
| 091393 |
005 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2009/08/31
|
AVANTHI INC |
| 091490 |
005 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2011/03/09
|
RHODES PHARMS |
| 202116 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2011/12/30
|
ALVOGEN |
| 202160 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2012/11/19
|
AUROLIFE PHARMA LLC |
| 203638 |
005 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2014/06/03
|
AMNEAL PHARMS |
| 202662 |
004 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2015/09/22
|
EPIC PHARMA LLC |
| 207119 |
005 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2016/04/12
|
NUVO PHARM |
| 204021 |
005 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2017/06/12
|
NOVEL LABS INC |
| 207418 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
30MG |
Prescription |
No |
No |
AB |
2017/08/07
|
ASCENT PHARMS INC |
活性成分:OXYCODONE 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 |
|---|
| 076758 |
003 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2007/03/19
|
SPECGX LLC |
| 090659 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/04/10
|
SUN PHARM INDS INC |
| 021011 |
003 |
NDA |
ROXICODONE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
Yes |
No |
AB |
2009/05/15
|
SPECGX LLC |
| 090895 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/08/24
|
EPIC PHARMA LLC |
| 091393 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2009/08/31
|
AVANTHI INC |
| 091490 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/03/09
|
RHODES PHARMS |
| 202116 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/12/30
|
ALVOGEN |
| 202160 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2012/11/19
|
AUROLIFE PHARMA LLC |
| 203638 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2014/06/03
|
AMNEAL PHARMS |
| 202662 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/09/22
|
EPIC PHARMA LLC |
| 207119 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2016/04/12
|
NUVO PHARM |
| 204021 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2017/06/12
|
NOVEL LABS INC |
