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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2025/10/28 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 无 |
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:TICAGRELOR; 剂型/给药途径:TABLET;ORAL; 规格:60MG; 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 |
|---|
| 022433 |
002 |
NDA |
BRILINTA |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
Yes |
No |
AB |
2015/09/03
|
ASTRAZENECA |
| 208390 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2018/09/04
|
WATSON LABS INC |
| 208597 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2021/07/09
|
MYLAN |
| 210219 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
ALKEM LABS LTD |
| 211498 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
TARO |
| 212258 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
MACLEODS PHARMS LTD |
| 216187 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
CHANGZHOU PHARM |
| 218962 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
SCIEGEN PHARMS INC |
| 208508 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
SUNSHINE |
| 208531 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
AMNEAL |
| 208537 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
INVAGEN PHARMS |
| 208541 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
DR REDDYS |
| 208576 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
ALEMBIC |
| 208584 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
APOTEX |
| 208596 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
60MG |
Prescription |
No |
No |
AB |
2025/10/28
|
MSN |
>>>活性成分:TICAGRELOR; 剂型/给药途径:TABLET;ORAL; 规格:90MG; 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 |
|---|
| 022433 |
001 |
NDA |
BRILINTA |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
Yes |
Yes |
AB |
2011/07/20
|
ASTRAZENECA |
| 208390 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2018/09/04
|
WATSON LABS INC |
| 208575 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2019/01/23
|
HISUN PHARM HANGZHOU |
| 208508 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2020/04/06
|
SUNSHINE |
| 208596 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2020/04/07
|
MSN |
| 208597 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2021/07/09
|
MYLAN |
| 208567 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2023/04/21
|
ALKEM LABS LTD |
| 208599 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2024/08/16
|
PRINSTON INC |
| 208541 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2024/10/29
|
DR REDDYS |
| 208576 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2025/05/01
|
ALEMBIC |
| 208584 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2025/05/01
|
APOTEX |
| 208537 |
001 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2025/05/05
|
INVAGEN PHARMS |
| 211498 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2025/10/28
|
TARO |
| 212258 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2025/10/28
|
MACLEODS PHARMS LTD |
| 216187 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2025/10/28
|
CHANGZHOU PHARM |
| 218962 |
002 |
ANDA |
TICAGRELOR |
TICAGRELOR |
TABLET;ORAL |
90MG |
Prescription |
No |
No |
AB |
2025/10/28
|
SCIEGEN PHARMS INC |