药品注册申请号:020541
申请类型:NDA (新药申请)
申请人:ANI PHARMS
申请人全名:ANI 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 ARIMIDEX ANASTROZOLE TABLET;ORAL 1MG Yes Yes AB 1995/12/27 1995/12/27 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
2018/12/13 SUPPL-31(补充) Approval Labeling STANDARD
2014/05/02 SUPPL-29(补充) Approval Labeling
2013/05/01 SUPPL-27(补充) Approval Labeling STANDARD
2011/04/18 SUPPL-26(补充) Approval Efficacy STANDARD
2009/04/30 SUPPL-25(补充) Approval Labeling STANDARD
2009/04/30 SUPPL-24(补充) Approval Efficacy UNKNOWN
2008/12/10 SUPPL-23(补充) Approval Labeling STANDARD
2008/12/10 SUPPL-21(补充) Approval Labeling STANDARD
2008/12/10 SUPPL-20(补充) Approval Labeling STANDARD
2006/05/10 SUPPL-18(补充) Approval Manufacturing (CMC) N/A
2005/09/16 SUPPL-16(补充) Approval Efficacy UNKNOWN
2004/08/30 SUPPL-15(补充) Approval Labeling STANDARD
2002/10/07 SUPPL-5(补充) Approval Labeling STANDARD
2002/09/05 SUPPL-10(补充) Approval Efficacy PRIORITY
2001/09/10 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
2001/08/02 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2000/09/01 SUPPL-6(补充) Approval Efficacy STANDARD
1998/08/13 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1998/02/06 SUPPL-2(补充) Approval Labeling STANDARD
1997/09/19 SUPPL-3(补充) Approval Labeling STANDARD
1996/10/18 SUPPL-1(补充) Approval Labeling STANDARD
1995/12/27 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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 RE36617 2009/12/27 PDF格式**本条是由Drugfuture回溯的历史信息**
RE36617 2009/12/27 Y Y U-946 PDF格式**本条是由Drugfuture回溯的历史信息**
RE36617*PED 2010/06/27 PDF格式**本条是由Drugfuture回溯的历史信息**
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 M-61 2011/12/05**本条是由Drugfuture回溯的历史信息**
PED 2012/06/05**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:ANASTROZOLE 剂型/给药途径:TABLET;ORAL 规格: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
020541 001 NDA ARIMIDEX ANASTROZOLE TABLET;ORAL 1MG Prescription Yes Yes AB 1995/12/27 ANI PHARMS
078058 001 ANDA ANASTROZOLE ANASTROZOLE TABLET;ORAL 1MG Prescription No No AB 2010/06/28 TEVA PHARMS
078921 001 ANDA ANASTROZOLE ANASTROZOLE TABLET;ORAL 1MG Prescription No No AB 2010/06/28 ZYDUS PHARMS USA INC
078944 001 ANDA ANASTROZOLE ANASTROZOLE TABLET;ORAL 1MG Prescription No No AB 2010/06/28 KENTON
079220 001 ANDA ANASTROZOLE ANASTROZOLE TABLET;ORAL 1MG Prescription No No AB 2010/06/28 NATCO PHARMA LTD
090568 001 ANDA ANASTROZOLE ANASTROZOLE TABLET;ORAL 1MG Prescription No No AB 2010/06/28 ACCORD HLTHCARE
091164 001 ANDA ANASTROZOLE ANASTROZOLE TABLET;ORAL 1MG Prescription No No AB 2010/06/28 CIPLA
206037 001 ANDA ANASTROZOLE ANASTROZOLE TABLET;ORAL 1MG Prescription No No AB 2018/11/09 BEIJING YILING
212434 001 ANDA ANASTROZOLE ANASTROZOLE TABLET;ORAL 1MG Prescription No No AB 2020/07/24 EUGIA PHARMA
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药品NDC数据与药品包装、标签说明书
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