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 |
|---|
| 2024/10/31 |
SUPPL-5（补充） |
Approval |
REMS |
|
|
|
| 2023/12/15 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/12/15 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/09/23 |
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:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:8MG 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 |
|---|
| 204278 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2015/04/06
|
PADAGIS US |
| 205629 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2016/07/07
|
OSMOTICA PHARM US |
| 212133 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
8MG |
Prescription |
No |
No |
AB |
2020/09/23
|
ASCENT PHARMS INC |
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:12MG 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 |
|---|
| 204278 |
002 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
12MG |
Prescription |
No |
No |
AB |
2015/04/06
|
PADAGIS US |
| 205629 |
002 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
12MG |
Prescription |
No |
No |
AB |
2016/07/07
|
OSMOTICA PHARM US |
| 212133 |
002 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
12MG |
Prescription |
No |
No |
AB |
2020/09/23
|
ASCENT PHARMS INC |
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:16MG 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 |
|---|
| 204278 |
003 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
16MG |
Prescription |
No |
No |
AB |
2015/04/06
|
PADAGIS US |
| 205629 |
003 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
16MG |
Prescription |
No |
No |
AB |
2016/07/07
|
OSMOTICA PHARM US |
| 212133 |
003 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
16MG |
Prescription |
No |
No |
AB |
2020/09/23
|
ASCENT PHARMS INC |
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:32MG 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 |
|---|
| 205629 |
004 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
32MG |
Prescription |
No |
Yes |
AB |
2016/07/07
|
OSMOTICA PHARM US |
| 204278 |
004 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
32MG |
Prescription |
No |
No |
AB |
2017/09/20
|
PADAGIS US |
| 212133 |
004 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
32MG |
Prescription |
No |
No |
AB |
2020/09/23
|
ASCENT PHARMS INC |