药品注册申请号:077182
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 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG No No AB 2006/01/24 2006/01/24 Prescription
002 DESOGESTREL; ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL TABLET; ORAL-28 0.125MG/0.025MG No None -- Prescription
003 DESOGESTREL; ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL TABLET; ORAL-28 0.15MG/0.025MG No None -- 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
2019/10/25 SUPPL 14 Approval Labeling STANDARD
2010/08/02 SUPPL 8 Approval Labeling
2009/03/19 SUPPL 4 Approval Labeling
2006/01/24 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:0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG 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
021090 001 NDA CYCLESSA DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG Prescription Yes Yes AB 2000/12/20 ASPEN GLOBAL INC
076455 001 ANDA VELIVET DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG Prescription No No AB 2004/02/24 DURAMED PHARMS BARR
077182 001 ANDA DESOGESTREL AND ETHINYL ESTRADIOL DESOGESTREL; ETHINYL ESTRADIOL TABLET;ORAL-28 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG Prescription No No AB 2006/01/24 MAYNE PHARMA
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