药品注册申请号:021840
申请类型:NDA (新药申请)
申请人:TEVA BRANDED PHARM
申请人全名:TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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 SEASONIQUE ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL 0.03MG,0.01MG;0.15MG,N/A Yes Yes AB 2006/05/25 2006/05/25 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
2017/08/09 SUPPL 11 Approval Labeling STANDARD
2014/09/22 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2010/07/29 SUPPL 8 Approval Efficacy STANDARD
2006/05/25 ORIG 1 Approval Type 3 - New Dosage Form 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
001 7320969 2024/01/30 U-828 PDF格式
7615545 2023/06/15 U-1 PDF格式
7855190 2028/12/05 U-1 2011/03/29 PDF格式
7858605 2023/06/23 Y 2011/01/28 PDF格式
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 NP 2009/05/25**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; 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 MAYNE PHARMA
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 GENERICS
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 MYLAN LABS LTD
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 LTD
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
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