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-46(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/01/16 |
SUPPL-37(补充) |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
2019/10/07 |
SUPPL-35(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/01/26 |
SUPPL-30(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/10 |
SUPPL-29(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2016/12/16 |
SUPPL-27(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/16 |
SUPPL-25(补充) |
Approval |
Manufacturing (CMC) |
N/A
|
|
|
2011/06/30 |
SUPPL-21(补充) |
Approval |
Labeling |
UNKNOWN
|
|
|
2009/04/30 |
SUPPL-18(补充) |
Approval |
Efficacy |
UNKNOWN
|
|
|
2006/06/12 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2001/11/09 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
2001/07/18 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
1994/08/08 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1994/08/04 |
SUPPL-6(补充) |
Approval |
Labeling |
|
|
|
1991/10/16 |
SUPPL-5(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1991/10/16 |
SUPPL-4(补充) |
Approval |
Manufacturing (CMC) |
PRIORITY
|
|
|
1984/02/29 |
SUPPL-1(补充) |
Approval |
Labeling |
|
|
|
1984/01/11 |
ORIG-1(原始申请) |
Approval |
Type 3 - New Dosage Form |
PRIORITY
|
|
|
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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:0.2MG/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 |
006 |
NDA |
DILAUDID |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/ML |
Prescription |
Yes |
Yes |
AP |
2020/01/16
|
FRESENIUS KABI USA |
216899 |
001 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.2MG/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:0.5MG/0.5ML 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 |
007 |
NDA |
DILAUDID |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5MG/0.5ML |
Prescription |
Yes |
Yes |
AP |
2017/02/10
|
FRESENIUS KABI USA |
216899 |
002 |
ANDA |
HYDROMORPHONE HYDROCHLORIDE |
HYDROMORPHONE HYDROCHLORIDE |
INJECTABLE;INJECTION |
0.5MG/0.5ML |
Prescription |
No |
No |
AP |
2024/02/09
|
HIKMA |