药品注册申请号:076916
申请类型:ANDA (仿制药申请)
申请人:MAYNE PHARMA
申请人全名:MAYNE PHARMA LLC
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 DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG No No AB 2008/12/29 2008/12/29 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
2017/08/09 SUPPL 12 Approval Labeling STANDARD
2013/03/29 SUPPL 6 Approval Labeling STANDARD
2008/12/29 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:DESOGESTREL; ETHINYL ESTRADIOL 剂型/给药途径:TABLET;ORAL-28 规格:0.15MG,N/A;0.02MG,0.01MG 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
075863 001 ANDA KARIVA DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No Yes AB 2002/04/05 BARR
076916 001 ANDA DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2008/12/29 MAYNE PHARMA
091346 001 ANDA VIORELE DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2012/04/02 GLENMARK GENERICS
091247 001 ANDA PIMTREA DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2013/08/01 NOVAST LABS
202296 001 ANDA DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2013/08/30 MYLAN LABS LTD
076681 001 ANDA KIMIDESS DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2015/04/30 VINTAGE PHARMS
202226 001 ANDA BEKYREE DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2015/08/12 LUPIN LTD
202689 001 ANDA VOLNEA DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2016/09/09 XIROMED
206853 001 ANDA SIMLIYA DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2017/03/22 AUROBINDO PHARMA LTD
209170 001 ANDA DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.15MG,N/A;0.02MG,0.01MG Prescription No No AB 2017/06/05 NAARI PTE LTD
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