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 |
|---|
| 2024/01/23 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/08/11 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
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:VARENICLINE TARTRATE 剂型/给药途径:TABLET;ORAL 规格:EQ 0.5MG 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 |
|---|
| 201785 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2021/08/11
|
ENDO OPERATIONS |
| 201962 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/01/25
|
APOTEX |
| 216723 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/06/12
|
ZYDUS |
| 217151 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/07/25
|
MEDLEY PHARMS |
| 214255 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/08/01
|
MANKIND PHARMA |
| 214557 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/08/23
|
ALKEM LABS LTD |
| 214571 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/10/23
|
HETERO LABS LTD III |
| 211862 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/12/04
|
LUPIN LTD |
| 202019 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2024/02/28
|
MYLAN |
| 217283 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2024/03/06
|
BIONPHARMA |
| 213019 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2024/03/19
|
AJANTA PHARMA LTD |
| 217115 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2024/07/23
|
PIRAMAL |
| 215931 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2024/10/01
|
DR REDDYS |
| 219106 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2024/10/29
|
INDOCO |
| 215048 |
001 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2024/12/09
|
MACLEODS PHARMS LTD |
活性成分:VARENICLINE TARTRATE 剂型/给药途径:TABLET;ORAL 规格:EQ 1MG 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 |
|---|
| 201785 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
Yes |
AB |
2021/08/11
|
ENDO OPERATIONS |
| 201962 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/01/25
|
APOTEX |
| 216723 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/06/12
|
ZYDUS |
| 217151 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/07/25
|
MEDLEY PHARMS |
| 214255 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/08/01
|
MANKIND PHARMA |
| 214557 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/08/23
|
ALKEM LABS LTD |
| 214571 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/10/23
|
HETERO LABS LTD III |
| 211862 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/12/04
|
LUPIN LTD |
| 202019 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/02/28
|
MYLAN |
| 217283 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/03/06
|
BIONPHARMA |
| 213019 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/03/19
|
AJANTA PHARMA LTD |
| 217115 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/07/23
|
PIRAMAL |
| 215931 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/10/01
|
DR REDDYS |
| 219106 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/10/29
|
INDOCO |
| 215048 |
002 |
ANDA |
VARENICLINE TARTRATE |
VARENICLINE TARTRATE |
TABLET;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/12/09
|
MACLEODS PHARMS LTD |
