药品注册申请号：076784
申请类型：ANDA (仿制药申请)
申请人：BARR LABS INC
申请人全名：BARR LABORATORIES 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 TRI LO SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG No No AB 2009/06/29 2009/06/29 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
2022/04/29 SUPPL-13（补充） Approval Labeling STANDARD
2022/01/28 SUPPL-8（补充） Approval Labeling STANDARD
2016/04/19 SUPPL-7（补充） Approval Labeling STANDARD
2012/11/26 SUPPL-5（补充） Approval Labeling STANDARD
2009/06/29 ORIG-1（原始申请） Approval
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:0.025MG,0.025MG,0.025MG;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
076784 001 ANDA TRI LO SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2009/06/29 BARR LABS INC
200541 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2012/06/25 LUPIN PHARMS
091232 001 ANDA TRI-LO-ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2015/06/29 XIROMED
204057 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Prescription No Yes AB 2016/02/23 GLENMARK SPECLT
203873 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2016/05/12 AMNEAL PHARMS
205762 001 ANDA TRI-LO-MILI ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2016/11/04 AUROBINDO PHARMA
090541 001 ANDA TRI-LO-LINYAH ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2022/09/02 NOVAST LABS
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药品NDC数据与药品包装、标签说明书
参考引用1
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