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 |
2024/01/16 |
SUPPL-21(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/05/01 |
SUPPL-19(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/02/04 |
SUPPL-18(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/02/04 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2021/02/04 |
SUPPL-11(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/10/05 |
SUPPL-9(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2013/03/14 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2012/11/02 |
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:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG BASE;EQ 3MG BASE 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 |
021520 |
001 |
NDA |
SYMBYAX |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 3MG BASE |
Prescription |
Yes |
No |
AB |
2007/04/09
|
LILLY |
077742 |
001 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2012/11/02
|
ENDO OPERATIONS |
078901 |
005 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2012/11/16
|
EPIC PHARMA LLC |
202074 |
001 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 3MG BASE |
Prescription |
No |
No |
AB |
2013/03/25
|
TEVA PHARMS |
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG BASE;EQ 6MG BASE 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 |
021520 |
002 |
NDA |
SYMBYAX |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 6MG BASE |
Prescription |
Yes |
No |
AB |
2003/12/24
|
LILLY |
077528 |
001 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/06/19
|
TEVA PHARMS |
077742 |
002 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/11/02
|
ENDO OPERATIONS |
078901 |
001 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/11/16
|
EPIC PHARMA LLC |
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG BASE;EQ 12MG BASE 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 |
021520 |
004 |
NDA |
SYMBYAX |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 12MG BASE |
Prescription |
Yes |
No |
AB |
2003/12/24
|
LILLY |
077528 |
002 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/06/19
|
TEVA PHARMS |
077742 |
003 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/11/02
|
ENDO OPERATIONS |
078901 |
003 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 25MG BASE;EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/11/16
|
EPIC PHARMA LLC |
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG BASE;EQ 6MG BASE 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 |
021520 |
003 |
NDA |
SYMBYAX |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 50MG BASE;EQ 6MG BASE |
Prescription |
Yes |
Yes |
AB |
2003/12/24
|
LILLY |
077528 |
003 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 50MG BASE;EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/06/19
|
TEVA PHARMS |
077742 |
004 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 50MG BASE;EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/11/02
|
ENDO OPERATIONS |
078901 |
002 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 50MG BASE;EQ 6MG BASE |
Prescription |
No |
No |
AB |
2012/11/16
|
EPIC PHARMA LLC |
活性成分:FLUOXETINE HYDROCHLORIDE; OLANZAPINE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 50MG BASE;EQ 12MG BASE 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 |
021520 |
005 |
NDA |
SYMBYAX |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 50MG BASE;EQ 12MG BASE |
Prescription |
Yes |
No |
AB |
2003/12/24
|
LILLY |
077528 |
004 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 50MG BASE;EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/06/19
|
TEVA PHARMS |
077742 |
005 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 50MG BASE;EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/11/02
|
ENDO OPERATIONS |
078901 |
004 |
ANDA |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
CAPSULE;ORAL |
EQ 50MG BASE;EQ 12MG BASE |
Prescription |
No |
No |
AB |
2012/11/16
|
EPIC PHARMA LLC |