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-48（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/07 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/11/21 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/09/03 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/07/16 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/08/18 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/06/11 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2011/12/01 |
ORIG-1（原始申请） |
Approval |
Type 7 - Drug Already Marketed without Approved NDA |
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:INJECTABLE;INJECTION 规格:1MG/ML 治疗等效代码:AP
| 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 |
|---|
| 019034 |
003 |
NDA |
DILAUDID |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
Yes |
Yes |
AP |
2009/04/30
|
FRESENIUS KABI USA |
| 200403 |
001 |
NDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2011/12/01
|
HOSPIRA INC |
| 216899 |
003 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1MG/ML |
Prescription |
No |
No |
AP |
2024/02/09
|
HIKMA |
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2MG/ML 治疗等效代码:AP
| 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 |
|---|
| 019034 |
004 |
NDA |
DILAUDID |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
Yes |
Yes |
AP |
2009/04/30
|
FRESENIUS KABI USA |
| 200403 |
002 |
NDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2011/12/01
|
HOSPIRA INC |
| 202159 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2018/04/27
|
HIKMA |
| 216899 |
004 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2MG/ML |
Prescription |
No |
No |
AP |
2024/02/09
|
HIKMA |
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:4MG/ML 治疗等效代码:AP
| 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 |
|---|
| 019034 |
005 |
NDA |
DILAUDID |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
4MG/ML |
Prescription |
Yes |
Yes |
AP |
2009/04/30
|
FRESENIUS KABI USA |
| 200403 |
003 |
NDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
4MG/ML |
Prescription |
No |
No |
AP |
2011/12/01
|
HOSPIRA INC |
