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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2010/10/20 |
ORIG-1（原始申请） |
Approval |
Type 7 - Drug Already Marketed without Approved NDA |
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2024/10/31 |
SUPPL-24（补充） |
Approval |
REMS - MODIFIED - D-N-A |
N/A
|
|
|
| 2024/04/19 |
SUPPL-23（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2023/12/15 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/07/21 |
SUPPL-17（补充） |
Approval |
Efficacy-New Dosing Regimen |
STANDARD
|
|
|
| 2021/03/04 |
SUPPL-19（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2019/10/07 |
SUPPL-16（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-15（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-14（补充） |
Approval |
REMS - PROPOSAL - D-N-A |
N/A
|
|
|
| 2016/12/16 |
SUPPL-11（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2015/09/01 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/06/20 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/10/08 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/08/22 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/08/22 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/01/25 |
SUPPL-4（补充） |
Approval |
REMS-Modified |
N/A
|
|
|
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:SOLUTION;ORAL; 规格:100MG/5ML; 治疗等效代码:AA<<<
| 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 |
|---|
| 200535 |
001 |
NDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
Yes |
Yes |
AA |
2010/10/20
|
GENUS LIFESCIENCES |
| 202537 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Discontinued |
No |
No |
AA |
2012/07/30
|
VISTAPHARM LLC |
| 204092 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Discontinued |
No |
No |
AA |
2014/06/05
|
DR REDDYS LABS SA |
| 208593 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2017/07/21
|
ABHAI LLC |
| 208795 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Discontinued |
No |
No |
AA |
2017/08/07
|
HIKMA |
| 206822 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Discontinued |
No |
No |
AA |
2017/08/15
|
PHARM ASSOC |
| 209897 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2017/09/06
|
HIBROW HLTHCARE |
| 209021 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2017/11/09
|
ASCENT PHARMS INC |
| 210758 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2018/04/30
|
SPECGX LLC |
| 211749 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2019/02/04
|
ALKEM LABS LTD |
| 213761 |
002 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
100MG/5ML |
Prescription |
No |
No |
AA |
2021/06/02
|
QUAGEN |
>>>活性成分:OXYCODONE HYDROCHLORIDE; 剂型/给药途径:SOLUTION;ORAL; 规格:5MG/5ML; 治疗等效代码:AA<<<
| 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 |
|---|
| 204037 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
Yes |
AA |
2013/07/15
|
HIKMA |
| 200535 |
002 |
NDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
Yes |
No |
AA |
2013/08/22
|
GENUS LIFESCIENCES |
| 204979 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2015/06/01
|
ANI PHARMS |
| 207511 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2016/11/23
|
HIBROW HLTHCARE |
| 208593 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2017/07/21
|
ABHAI LLC |
| 208817 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Discontinued |
No |
No |
AA |
2017/08/10
|
HIKMA |
| 209021 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2017/11/09
|
ASCENT PHARMS INC |
| 210758 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2018/04/30
|
SPECGX LLC |
| 206914 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2019/02/01
|
PHARM ASSOC |
| 211748 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2019/02/07
|
ALKEM LABS LTD |
| 213761 |
001 |
ANDA |
OXYCODONE HYDROCHLORIDE |
OXYCODONE HYDROCHLORIDE |
SOLUTION;ORAL |
5MG/5ML |
Prescription |
No |
No |
AA |
2021/06/02
|
QUAGEN |
