药品注册申请号:020498
申请类型:NDA (新药申请)
申请人:ANI PHARMS INC
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 CASODEX BICALUTAMIDE TABLET;ORAL 50MG Yes Yes AB 1995/10/04 1995/10/04 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
2017/11/01 SUPPL 28 Approval Labeling STANDARD
2017/03/17 SUPPL 27 Approval Labeling STANDARD
2015/02/27 SUPPL 25 Approval Labeling STANDARD
2013/09/12 SUPPL 24 Approval Manufacturing (CMC) STANDARD
2010/09/15 SUPPL 22 Approval Labeling STANDARD
2009/03/13 SUPPL 21 Approval Labeling STANDARD
2009/03/13 SUPPL 19 Approval Labeling STANDARD
2006/03/10 SUPPL 18 Approval Labeling STANDARD
2005/05/11 SUPPL 16 Approval Labeling STANDARD
2002/09/23 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2002/01/25 SUPPL 11 Approval Manufacturing (CMC) STANDARD
2001/10/25 SUPPL 10 Approval Manufacturing (CMC) STANDARD
2001/02/28 SUPPL 8 Approval Labeling STANDARD
2000/12/11 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1999/11/04 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1997/12/12 SUPPL 4 Approval Efficacy STANDARD
1997/11/12 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1995/10/04 ORIG 1 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 4636505 2008/10/01 PDF格式**本条是由Drugfuture回溯的历史信息**
4636505 2008/10/01 Y Y U-937 PDF格式**本条是由Drugfuture回溯的历史信息**
4636505*PED 2009/04/01 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-81 2011/12/19**本条是由Drugfuture回溯的历史信息**
PED 2012/06/19**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:BICALUTAMIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
020498 001 NDA CASODEX BICALUTAMIDE TABLET;ORAL 50MG Prescription Yes Yes AB 1995/10/04 ANI PHARMS INC
078575 001 ANDA BICALUTAMIDE BICALUTAMIDE TABLET;ORAL 50MG Prescription No No AB 2009/07/06 SANDOZ
078917 001 ANDA BICALUTAMIDE BICALUTAMIDE TABLET;ORAL 50MG Prescription No No AB 2009/07/06 ACCORD HLTHCARE
079089 001 ANDA BICALUTAMIDE BICALUTAMIDE TABLET;ORAL 50MG Prescription No No AB 2009/07/06 ZYDUS PHARMS USA INC
079110 001 ANDA BICALUTAMIDE BICALUTAMIDE TABLET;ORAL 50MG Prescription No No AB 2009/07/06 SUN PHARM
078634 001 ANDA BICALUTAMIDE BICALUTAMIDE TABLET;ORAL 50MG Prescription No No AB 2009/08/28 WATSON LABS TEVA
200274 001 ANDA BICALUTAMIDE BICALUTAMIDE TABLET;ORAL 50MG Prescription No No AB 2015/05/21 APOTEX INC
091011 001 ANDA BICALUTAMIDE BICALUTAMIDE TABLET;ORAL 50MG Prescription No No AB 2015/06/10 KENTON
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