药品注册申请号：208596
申请类型：ANDA (仿制药申请)
申请人：MSN
申请人全名：MSN LABORATORIES PRIVATE LTD
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 TICAGRELOR TICAGRELOR TABLET;ORAL 90MG No No AB;AB 2020/04/07 2020/04/07 Prescription
002 TICAGRELOR TICAGRELOR TABLET;ORAL 60MG No No AB;AB 2025/10/28 Prescription
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-2（原始申请） Approval STANDARD
2020/04/07 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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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: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RLDRSTE 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
>>>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RLDRSTE 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
>>>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RLDRSTE 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: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RLDRSTE 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
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