药品注册申请号:075804
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 SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG No Yes AB 2002/09/25 2002/09/25 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 27 Approval Labeling STANDARD
2016/04/13 SUPPL 26 Approval Labeling STANDARD
2013/01/31 SUPPL 25 Approval Labeling STANDARD
2011/08/31 SUPPL 23 Approval Labeling
2002/09/25 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;0.25MG 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
075804 001 ANDA SPRINTEC ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No Yes AB 2002/09/25 BARR
076334 001 ANDA PREVIFEM ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2004/01/09 VINTAGE PHARMS LLC
200538 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2012/04/05 GLENMARK GENERICS
090523 001 ANDA MONO-LINYAH ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2012/05/23 NOVAST LABS LTD
090794 001 ANDA ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2013/01/30 XIROMED
200384 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2015/04/07 NAARI PTE LTD
203865 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2015/10/27 AMNEAL PHARMS
201896 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2016/01/27 MYLAN LABS LTD
205449 001 ANDA MILI ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2016/07/07 AUROBINDO PHARMA LTD
205630 001 ANDA NORGESTIMATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORGESTIMATE TABLET;ORAL-28 0.035MG;0.25MG Prescription No No AB 2016/10/27 LUPIN LTD
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