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 |
|---|
| 2023/08/18 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/09/20 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/04/08 |
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:FLUOXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG 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 |
|---|
| 075872 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2002/01/29
|
TEVA |
| 076006 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2002/01/30
|
DR REDDYS |
| 203836 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2016/08/19
|
ENDO OPERATIONS |
| 208698 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2017/04/05
|
ALEMBIC |
| 211696 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2019/01/30
|
UPSHER SMITH LABS |
| 210935 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2019/03/20
|
SCIEGEN PHARMS INC |
| 211653 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2019/04/15
|
LUPIN LTD |
| 213286 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2020/04/08
|
AUROBINDO PHARMA LTD |
| 211444 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
2022/09/13
|
ADAPTIS |
| 212684 |
001 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2024/04/05
|
STRIDES PHARMA |
活性成分:FLUOXETINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 20MG 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 |
|---|
| 203836 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2016/08/19
|
ENDO OPERATIONS |
| 208698 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2017/04/05
|
ALEMBIC |
| 076006 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
Yes |
AB |
2018/04/23
|
DR REDDYS |
| 075872 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2019/01/04
|
TEVA |
| 211696 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2019/01/30
|
UPSHER SMITH LABS |
| 210935 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2019/03/20
|
SCIEGEN PHARMS INC |
| 211653 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2019/04/15
|
LUPIN LTD |
| 213286 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2020/04/08
|
AUROBINDO PHARMA LTD |
| 211444 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Discontinued |
No |
No |
AB |
2022/09/13
|
ADAPTIS |
| 212684 |
002 |
ANDA |
FLUOXETINE HYDROCHLORIDE |
FLUOXETINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 20MG BASE |
Prescription |
No |
No |
AB |
2024/04/05
|
STRIDES PHARMA |