药品注册申请号：210609
申请类型：ANDA (仿制药申请)
申请人：PRINSTON INC
申请人全名：PRINSTON PHARMACEUTICAL INC
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 TADALAFIL TADALAFIL TABLET;ORAL 2.5MG No No AB1 2022/08/11 2022/08/11 Prescription
002 TADALAFIL TADALAFIL TABLET;ORAL 5MG No No AB1 2022/08/11 Prescription
003 TADALAFIL TADALAFIL TABLET;ORAL 10MG No No AB1 2022/08/11 Prescription
004 TADALAFIL TADALAFIL TABLET;ORAL 20MG No No AB1 2022/08/11 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
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
2023/01/27 SUPPL-1（补充） Approval Labeling STANDARD
2022/08/11 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:TADALAFIL 剂型/给药途径:TABLET;ORAL 规格:2.5MG 治疗等效代码:AB1
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
021368 004 NDA CIALIS TADALAFIL TABLET;ORAL 2.5MG Discontinued Yes No AB1 2008/01/07 LILLY
090141 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2018/05/22 TEVA PHARMS USA
204809 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 ALEMBIC
206285 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 AUROBINDO PHARMA LTD
206693 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 ZYDUS PHARMS
208934 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 SUN PHARM
209167 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 ACCORD HLTHCARE
209250 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 UNICHEM
209539 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 CIPLA
209654 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 AJANTA PHARMA LTD
209744 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 AMNEAL PHARMS CO
209908 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 HETERO LABS LTD III
210069 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 DR REDDYS
210420 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 QILU PHARM HAINAN
210567 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 LUPIN LTD
211335 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 SUNSHINE
211839 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/26 TORRENT
205885 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/03/29 WATSON LABS INC
207244 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2019/10/07 MACLEODS PHARMS LTD
208824 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2020/10/27 HANGZHOU BINJIANG
215556 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2021/11/04 VKT PHARMA
210609 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2022/08/11 PRINSTON INC
217606 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 2.5MG Prescription No No AB1 2024/08/13 HIBROW HLTHCARE
活性成分:TADALAFIL 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AB1
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
021368 001 NDA CIALIS TADALAFIL TABLET;ORAL 5MG Prescription Yes No AB1 2003/11/21 LILLY
090141 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2018/05/22 TEVA PHARMS USA
204809 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 ALEMBIC
206285 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 AUROBINDO PHARMA LTD
206693 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 ZYDUS PHARMS
208934 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 SUN PHARM
209167 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 ACCORD HLTHCARE
209250 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 UNICHEM
209539 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 CIPLA
209654 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 AJANTA PHARMA LTD
209744 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 AMNEAL PHARMS CO
209908 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 HETERO LABS LTD III
210069 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 DR REDDYS
210420 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 QILU PHARM HAINAN
210567 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 LUPIN LTD
211335 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 SUNSHINE
211839 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/26 TORRENT
205885 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/03/29 WATSON LABS INC
207244 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2019/10/07 MACLEODS PHARMS LTD
208824 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2020/10/27 HANGZHOU BINJIANG
215556 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2021/11/04 VKT PHARMA
210609 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2022/08/11 PRINSTON INC
215949 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2023/03/03 NOVITIUM PHARMA
217606 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 5MG Prescription No No AB1 2024/08/13 HIBROW HLTHCARE
活性成分:TADALAFIL 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB1
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
021368 002 NDA CIALIS TADALAFIL TABLET;ORAL 10MG Prescription Yes No AB1 2003/11/21 LILLY
090141 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2018/05/22 TEVA PHARMS USA
204809 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 ALEMBIC
206285 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 AUROBINDO PHARMA LTD
206693 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 ZYDUS PHARMS
209250 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 UNICHEM
209539 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 CIPLA
209654 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 AJANTA PHARMA LTD
209744 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 AMNEAL PHARMS CO
209908 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 HETERO LABS LTD III
210069 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 DR REDDYS
210420 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 QILU PHARM HAINAN
210567 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 LUPIN LTD
211335 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 SUNSHINE
211839 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 TORRENT
208934 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/26 SUN PHARM
205885 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/03/29 WATSON LABS INC
207244 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/10/07 MACLEODS PHARMS LTD
209167 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2019/10/23 ACCORD HLTHCARE
208824 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2020/10/27 HANGZHOU BINJIANG
215556 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2021/11/04 VKT PHARMA
210609 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2022/08/11 PRINSTON INC
215949 002 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2023/03/03 NOVITIUM PHARMA
217606 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 10MG Prescription No No AB1 2024/08/13 HIBROW HLTHCARE
活性成分:TADALAFIL 剂型/给药途径:TABLET;ORAL 规格:20MG 治疗等效代码:AB1
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
021368 003 NDA CIALIS TADALAFIL TABLET;ORAL 20MG Prescription Yes Yes AB1 2003/11/21 LILLY
090141 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2018/05/22 TEVA PHARMS USA
204809 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 ALEMBIC
206285 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 AUROBINDO PHARMA LTD
206693 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 ZYDUS PHARMS
208934 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 SUN PHARM
209167 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 ACCORD HLTHCARE
209250 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 UNICHEM
209539 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 CIPLA
209654 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 AJANTA PHARMA LTD
209744 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 AMNEAL PHARMS CO
209908 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 HETERO LABS LTD III
210069 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 DR REDDYS
210420 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 QILU PHARM HAINAN
210567 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 LUPIN LTD
211335 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 SUNSHINE
211839 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/26 TORRENT
205885 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/03/29 WATSON LABS INC
207244 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2019/10/07 MACLEODS PHARMS LTD
208824 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2020/10/27 HANGZHOU BINJIANG
215556 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2021/11/04 VKT PHARMA
210609 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2022/08/11 PRINSTON INC
215949 003 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2023/03/03 NOVITIUM PHARMA
216279 001 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2024/03/04 SHANDONG
217606 004 ANDA TADALAFIL TADALAFIL TABLET;ORAL 20MG Prescription No No AB1 2024/08/13 HIBROW HLTHCARE
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药品NDC数据与药品包装、标签说明书
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