药品注册申请号:212706
申请类型:ANDA (仿制药申请)
申请人:WILSHIRE PHARMS INC
申请人全名:WILSHIRE PHARMACEUTICALS 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 MERZEE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG No No AB 2020/12/18 2020/12/18 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
2023/09/22 SUPPL-2(补充) Approval Labeling STANDARD
2023/09/22 SUPPL-1(补充) Approval Labeling STANDARD
2020/12/18 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
001 CGT 2021/07/17**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 剂型/给药途径:CAPSULE;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
204426 001 NDA TAYTULLA ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG Prescription Yes Yes AB 2013/04/19 APIL
213317 001 ANDA GEMMILY ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG Prescription No No AB 2020/11/09 XIROMED
212706 001 ANDA MERZEE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG Prescription No No AB 2020/12/18 WILSHIRE PHARMS INC
214292 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG Discontinued No No AB 2021/07/20 AMNEAL PHARMS
213901 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG Discontinued No No AB 2022/04/28 DR REDDYS LABS SA
213418 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE CAPSULE;ORAL 0.02MG;1MG Prescription No No AB 2022/07/27 GLENMARK PHARMS LTD
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药品NDC数据与药品包装、标签说明书
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