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 |
2021/11/12 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/11/12 |
SUPPL-8(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/11/12 |
SUPPL-7(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/11/12 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/11/12 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/04/04 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2019/04/04 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/07/03 |
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:HALOPERIDOL DECANOATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG BASE/ML 治疗等效代码:AO
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 |
018701 |
001 |
NDA |
HALDOL |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
Yes |
Yes |
AO |
1986/01/14
|
JANSSEN PHARMS |
074893 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
No |
No |
AO |
1997/12/19
|
FRESENIUS KABI USA |
074811 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
No |
No |
AO |
1998/01/30
|
HIKMA |
075393 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Discontinued |
No |
No |
AO |
1999/05/11
|
TEVA PHARMS USA |
075440 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
No |
No |
AO |
2000/02/28
|
MYLAN LABS LTD |
205241 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
No |
No |
AO |
2017/05/12
|
GLAND PHARMA LTD |
209101 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
No |
No |
AO |
2018/07/03
|
SOMERSET THERAPS LLC |
211180 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
No |
No |
AO |
2019/10/22
|
ZYDUS PHARMS |
214507 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
No |
No |
AO |
2021/07/26
|
MEITHEAL |
216730 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 50MG BASE/ML |
Prescription |
No |
No |
AO |
2023/05/23
|
MANKIND PHARMA |
活性成分:HALOPERIDOL DECANOATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 100MG BASE/ML 治疗等效代码:AO
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 |
018701 |
002 |
NDA |
HALDOL |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
Yes |
Yes |
AO |
1997/01/31
|
JANSSEN PHARMS |
074893 |
002 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
No |
No |
AO |
1997/12/19
|
FRESENIUS KABI USA |
075305 |
001 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
No |
No |
AO |
1998/09/28
|
HIKMA |
075393 |
002 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Discontinued |
No |
No |
AO |
1999/05/11
|
TEVA PHARMS USA |
075440 |
002 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
No |
No |
AO |
2000/02/28
|
MYLAN LABS LTD |
205241 |
002 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
No |
No |
AO |
2017/05/12
|
GLAND PHARMA LTD |
209101 |
002 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
No |
No |
AO |
2018/07/03
|
SOMERSET THERAPS LLC |
211180 |
002 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
No |
No |
AO |
2019/10/22
|
ZYDUS PHARMS |
214507 |
002 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
No |
No |
AO |
2021/07/26
|
MEITHEAL |
216730 |
002 |
ANDA |
HALOPERIDOL DECANOATE |
HALOPERIDOL DECANOATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/ML |
Prescription |
No |
No |
AO |
2023/05/23
|
MANKIND PHARMA |