药品注册申请号:210612
申请类型:ANDA (仿制药申请)
申请人:NOVAST LABS
申请人全名:NOVAST LABORATORIES LTD
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 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.5MG;0.1MG No No AB 2019/04/03 2019/04/03 Prescription
002 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG No No AB 2019/04/03 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
2024/05/31 SUPPL-5(补充) Approval Labeling STANDARD
2023/10/18 SUPPL-3(补充) Approval Labeling STANDARD
2019/04/03 ORIG-1(原始申请) Approval STANDARD
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:ESTRADIOL; NORETHINDRONE ACETATE 剂型/给药途径:TABLET;ORAL 规格:0.5MG;0.1MG 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
078324 002 ANDA ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.5MG;0.1MG Prescription No No AB 2011/06/09 BRECKENRIDGE PHARM
207261 001 ANDA ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.5MG;0.1MG Prescription No No AB 2017/02/10 XIROMED
210612 001 ANDA ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.5MG;0.1MG Prescription No No AB 2019/04/03 NOVAST LABS
214729 001 ANDA ETYQA ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.5MG;0.1MG Discontinued No No AB 2023/06/30 AUROBINDO PHARMA LTD
活性成分:ESTRADIOL; NORETHINDRONE ACETATE 剂型/给药途径:TABLET;ORAL 规格:1MG;0.5MG 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
020907 001 NDA ACTIVELLA ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG Prescription Yes Yes AB 1998/11/18 AMNEAL
078324 001 ANDA ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG Prescription No No AB 2008/04/17 BRECKENRIDGE PHARM
079193 001 ANDA ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG Prescription No No AB 2010/05/11 BARR
207261 002 ANDA ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG Prescription No No AB 2017/02/10 XIROMED
210233 001 ANDA ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG Prescription No No AB 2018/02/28 NAARI PTE LTD
210612 002 ANDA ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG Prescription No No AB 2019/04/03 NOVAST LABS
214729 002 ANDA ETYQA ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 1MG;0.5MG Discontinued No No AB 2023/06/30 AUROBINDO PHARMA LTD
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