药品注册申请号：200492
申请类型：ANDA (仿制药申请)
申请人：XIROMED
申请人全名：XIROMED 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 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A No No AB 2015/05/27 2015/05/27 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
2019/01/24 SUPPL-5（补充） Approval Labeling STANDARD
2015/05/27 ORIG-1（原始申请） Approval Not Applicable
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; LEVONORGESTREL 剂型/给药途径:TABLET;ORAL 规格:0.03MG,0.01MG;0.15MG,N/A 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
021840 001 NDA SEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription Yes Yes AB 2006/05/25 TEVA BRANDED PHARM
078834 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription No No AB 2011/05/31 DR REDDYS LABS SA
091467 001 ANDA DAYSEE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription No No AB 2013/04/10 LUPIN LTD
203163 001 ANDA ASHLYNA ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription No No AB 2015/02/23 GLENMARK PHARMS LTD
200492 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription No No AB 2015/05/27 XIROMED
203872 001 ANDA LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription No No AB 2015/12/22 AMNEAL PHARMS
206851 001 ANDA SIMPESSE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription No No AB 2017/04/07 AUROBINDO PHARMA
203770 001 ANDA JAIMIESS ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription No No AB 2017/12/27 XIROMED
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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