药品注册申请号：209222
申请类型：ANDA (仿制药申请)
申请人：ALKEM LABS LTD
申请人全名：ALKEM LABORATORIES 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 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG No No AB 2017/12/22 2017/12/22 Prescription
002 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG No No AB 2017/12/22 Prescription
003 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG No No AB 2017/12/22 Prescription
004 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG No No AB 2017/12/22 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
2017/12/22 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
2024/07/15 SUPPL-14（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2022/12/16 SUPPL-12（补充） Approval Labeling-Medication Guide,Labeling-Container/Carton Labels,Labeling-Package Insert STANDARD
2021/02/23 SUPPL-8（补充） Approval Labeling-Package Insert STANDARD
2020/01/29 SUPPL-6（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2019/09/26 SUPPL-5（补充） Approval Labeling-Package Insert STANDARD
2019/04/16 SUPPL-2（补充） Approval Labeling-Medication Guide,Labeling-Package Insert 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:EZETIMIBE; SIMVASTATIN; 剂型/给药途径:TABLET;ORAL; 规格:10MG;10MG; 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
021687 001 NDA VYTORIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Prescription Yes No AB 2004/07/23 ORGANON
200909 001 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Prescription No No AB 2017/04/26 DR REDDYS LABS SA
202968 001 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Prescription No No AB 2017/04/26 WATSON LABS INC
208831 001 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Discontinued No No AB 2017/11/21 AMNEAL PHARMS CO
209222 001 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Prescription No No AB 2017/12/22 ALKEM LABS LTD
208699 001 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Prescription No No AB 2019/06/27 GLENMARK PHARMS LTD
200082 001 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Prescription No No AB 2020/12/17 AUROBINDO PHARMA USA
211663 001 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Discontinued No No AB 2024/12/10 SCIEGEN PHARMS INC
209461 001 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;10MG Discontinued No No AB 2025/01/27 TORRENT
>>>活性成分:EZETIMIBE; SIMVASTATIN; 剂型/给药途径:TABLET;ORAL; 规格:10MG;20MG; 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
021687 002 NDA VYTORIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Prescription Yes No AB 2004/07/23 ORGANON
200909 002 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Prescription No No AB 2017/04/26 DR REDDYS LABS SA
202968 002 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Prescription No No AB 2017/04/26 WATSON LABS INC
208831 002 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Discontinued No No AB 2017/11/21 AMNEAL PHARMS CO
209222 002 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Prescription No No AB 2017/12/22 ALKEM LABS LTD
208699 002 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Prescription No No AB 2019/06/27 GLENMARK PHARMS LTD
200082 002 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Prescription No No AB 2020/12/17 AUROBINDO PHARMA USA
211663 002 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Discontinued No No AB 2024/12/10 SCIEGEN PHARMS INC
209461 002 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;20MG Discontinued No No AB 2025/01/27 TORRENT
>>>活性成分:EZETIMIBE; SIMVASTATIN; 剂型/给药途径:TABLET;ORAL; 规格:10MG;40MG; 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
021687 003 NDA VYTORIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Prescription Yes No AB 2004/07/23 ORGANON
200909 003 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Prescription No No AB 2017/04/26 DR REDDYS LABS SA
202968 003 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Prescription No No AB 2017/04/26 WATSON LABS INC
208831 003 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Discontinued No No AB 2017/11/21 AMNEAL PHARMS CO
209222 003 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Prescription No No AB 2017/12/22 ALKEM LABS LTD
208699 003 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Prescription No No AB 2019/06/27 GLENMARK PHARMS LTD
200082 003 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Prescription No No AB 2020/12/17 AUROBINDO PHARMA USA
211663 003 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Discontinued No No AB 2024/12/10 SCIEGEN PHARMS INC
209461 003 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;40MG Discontinued No No AB 2025/01/27 TORRENT
>>>活性成分:EZETIMIBE; SIMVASTATIN; 剂型/给药途径:TABLET;ORAL; 规格:10MG;80MG; 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
021687 004 NDA VYTORIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Prescription Yes Yes AB 2004/07/23 ORGANON
200909 004 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Prescription No No AB 2017/04/26 DR REDDYS LABS SA
202968 004 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Prescription No No AB 2017/04/26 WATSON LABS INC
208831 004 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Discontinued No No AB 2017/11/21 AMNEAL PHARMS CO
209222 004 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Prescription No No AB 2017/12/22 ALKEM LABS LTD
208699 004 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Prescription No No AB 2019/06/27 GLENMARK PHARMS LTD
200082 004 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Prescription No No AB 2020/12/17 AUROBINDO PHARMA USA
211663 004 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Discontinued No No AB 2024/12/10 SCIEGEN PHARMS INC
209461 004 ANDA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET;ORAL 10MG;80MG Discontinued No No AB 2025/01/27 TORRENT
更多信息
药品NDC数据与药品包装、标签说明书
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