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-6（补充） |
Approval |
REMS |
|
|
|
| 2020/04/07 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/04/07 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/04/07 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-2（补充） |
Approval |
REMS |
|
|
|
| 2016/05/13 |
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;ORAL 规格:2MG 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 |
|---|
| 078439 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
--
|
LANNETT |
| 076855 |
002 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2007/09/19
|
SPECGX LLC |
| 019892 |
003 |
NDA |
DILAUDID |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
2MG |
Prescription |
Yes |
No |
AB |
2007/11/09
|
RHODES PHARMS |
| 205814 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2016/05/13
|
AUROLIFE PHARMA LLC |
| 210506 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2018/01/17
|
ASCENT PHARMS INC |
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:4MG 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 |
|---|
| 078439 |
002 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
--
|
LANNETT |
| 076855 |
003 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2007/09/19
|
SPECGX LLC |
| 019892 |
002 |
NDA |
DILAUDID |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
4MG |
Prescription |
Yes |
No |
AB |
2007/11/09
|
RHODES PHARMS |
| 074597 |
003 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
4MG |
Discontinued |
No |
No |
AB |
2009/05/29
|
HIKMA |
| 205814 |
002 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2016/05/13
|
AUROLIFE PHARMA LLC |
| 210506 |
002 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
4MG |
Prescription |
No |
No |
AB |
2018/01/17
|
ASCENT PHARMS INC |
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET;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 |
|---|
| 019892 |
001 |
NDA |
DILAUDID |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
8MG |
Prescription |
Yes |
Yes |
AB |
1992/12/07
|
RHODES PHARMS |
| 074597 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
8MG |
Discontinued |
No |
No |
AB |
1998/07/29
|
HIKMA |
| 076855 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2004/12/23
|
SPECGX LLC |
| 205814 |
003 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2016/05/13
|
AUROLIFE PHARMA LLC |
| 210506 |
003 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
TABLET;ORAL |
8MG |
Prescription |
No |
No |
AB |
2018/01/17
|
ASCENT PHARMS INC |