药品注册申请号:075808
申请类型:ANDA (仿制药申请)
申请人:BARR
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-SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG No No AB 2003/12/29 2003/12/29 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/04/13 SUPPL 31 Approval Labeling STANDARD
2016/04/13 SUPPL 30 Approval Labeling STANDARD
2013/02/21 SUPPL 29 Approval Labeling STANDARD
2003/12/29 ORIG 1 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
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
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
019697 001 NDA ORTHO TRI-CYCLEN ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription Yes Yes AB 1992/07/03 JANSSEN PHARMS
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
076335 001 ANDA TRI-PREVIFEM ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG Prescription No No AB 2004/03/26 VINTAGE PHARMS LLC
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 No AB 2011/06/17 GLENMARK GENERICS
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
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 Prescription No No AB 2015/11/12 AMNEAL PHARMS
201897 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 2016/01/27 MYLAN LABS LTD
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
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