药品注册申请号：205588
申请类型：ANDA (仿制药申请)
申请人：LUPIN LTD
申请人全名：LUPIN 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 NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG No No AB 2016/04/26 2016/04/26 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
2016/04/26 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
2023/08/23 SUPPL-13（补充） Approval Labeling-Package Insert,Labeling-Patient Package Insert STANDARD
2023/08/23 SUPPL-12（补充） Approval Labeling-Package Insert STANDARD
2023/08/23 SUPPL-11（补充） Approval Labeling-Patient Package Insert,Labeling-Container/Carton Labels,Labeling-Package Insert STANDARD
2022/04/29 SUPPL-9（补充） Approval Labeling-Package Insert STANDARD
2021/10/18 SUPPL-8（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2019/07/03 SUPPL-6（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert
2019/04/26 SUPPL-3（补充） Approval Labeling-Package Insert,Labeling-Patient 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:ETHINYL ESTRADIOL; NORGESTIMATE; 剂型/给药途径:TABLET;ORAL-28; 规格:0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG; 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
075808 001 ANDA TRI-SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2003/12/29 BARR
200494 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription No Yes AB 2011/06/17 GLENMARK PHARMS LTD
090524 001 ANDA TRI-LINYAH ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2012/05/30 NOVAST LABS LTD
090793 001 ANDA TRI-ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2013/01/30 XIROMED
200383 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2015/04/07 NAARI PTE
203870 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Discontinued No No AB 2015/11/12 NAARI PTE
205588 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2016/04/26 LUPIN LTD
205441 001 ANDA TRI-MILI ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2016/07/06 AUROBINDO PHARMA LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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