药品注册申请号：090938
申请类型：ANDA (仿制药申请)
申请人：BARR LABS INC
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 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG No No AB 2014/12/01 2014/12/01 Prescription
002 FERROUS FUMARATE FERROUS FUMARATE TABLET; ORAL 75MG No No None -- None (Tentative Approval)
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
2022/04/29 SUPPL-12（补充） Approval Labeling STANDARD
2022/02/16 SUPPL-11（补充） Approval Labeling STANDARD
2022/02/16 SUPPL-3（补充） Approval Labeling STANDARD
2022/02/16 SUPPL-2（补充） Approval Labeling STANDARD
2014/12/01 ORIG-1（原始申请） 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
无
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
无
与本品治疗等效的药品
活性成分:ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 剂型/给药途径:TABLET;ORAL 规格:0.02MG;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
078267 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Discontinued No No AB 2009/09/01 AMNEAL PHARMS
090293 001 ANDA GILDESS 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No No AB 2014/12/01 ENDO OPERATIONS
090938 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No No AB 2014/12/01 BARR LABS INC
202994 001 ANDA LARIN 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No No AB 2015/02/18 NOVAST LABS
091398 001 ANDA BLISOVI 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No No AB 2015/10/28 LUPIN LTD
206287 001 ANDA MIBELAS 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No No AB 2016/05/24 LUPIN
207504 001 ANDA AUROVELA 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No No AB 2017/06/15 AUROBINDO PHARMA
204847 001 ANDA HAILEY 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No Yes AB 2017/11/17 GLENMARK PHARMS LTD
210369 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No Yes AB 2017/12/26 GLENMARK PHARMS LTD
209609 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No No AB 2018/07/16 XIROMED
210087 001 ANDA FINZALA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Prescription No No AB 2020/04/07 TEVA PHARMS USA INC
216558 001 ANDA OSHIH ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL 0.02MG;1MG Discontinued No No AB 2023/12/06 AUROBINDO PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
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