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 |
2024/08/27 |
SUPPL-36(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/12/15 |
SUPPL-34(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/12/01 |
SUPPL-29(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/10/16 |
SUPPL-28(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/16 |
SUPPL-26(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/12/16 |
SUPPL-25(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2007/11/30 |
SUPPL-18(补充) |
Approval |
Labeling |
|
|
|
2002/10/25 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/07/12 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/05/05 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/02/27 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/02/27 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/02/27 |
SUPPL-9(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/10/03 |
SUPPL-8(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1996/04/26 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
1991/02/28 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
1990/07/25 |
SUPPL-2(补充) |
Approval |
Labeling |
|
|
|
1989/02/03 |
ORIG-1(原始申请) |
Approval |
|
|
|
|
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:NALBUPHINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/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 |
070914 |
001 |
ANDA |
NALBUPHINE HYDROCHLORIDE |
NALBUPHINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
Yes |
AP |
1989/02/03
|
HOSPIRA |
070915 |
001 |
ANDA |
NALBUPHINE HYDROCHLORIDE |
NALBUPHINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
Yes |
AP |
1989/02/03
|
HOSPIRA |
216049 |
001 |
ANDA |
NALBUPHINE HYDROCHLORIDE |
NALBUPHINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2024/09/19
|
SOMERSET THERAPS LLC |
216050 |
001 |
ANDA |
NALBUPHINE HYDROCHLORIDE |
NALBUPHINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2024/09/19
|
SOMERSET THERAPS LLC |