药品注册申请号:020788
申请类型:NDA (新药申请)
申请人:MERCK
申请人全名:MERCK RESEARCH LABORATORIES DIV MERCK CO 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 PROPECIA FINASTERIDE TABLET;ORAL 1MG Yes Yes AB 1997/12/19 1997/12/19 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
2016/01/11 SUPPL 26 Approval Manufacturing (CMC) STANDARD
2014/01/31 SUPPL 24 Approval Labeling STANDARD
2012/04/11 SUPPL 23 Approval Labeling UNKNOWN
2012/04/11 SUPPL 21 Approval Labeling UNKNOWN
2012/04/11 SUPPL 20 Approval Labeling UNKNOWN
2011/06/10 SUPPL 16 Approval Labeling UNKNOWN
2011/06/09 SUPPL 22 Approval Labeling UNKNOWN
2011/04/13 SUPPL 18 Approval Labeling UNKNOWN
2011/03/11 SUPPL 17 Approval Labeling UNKNOWN
2010/03/24 SUPPL 15 Approval Labeling UNKNOWN
2006/11/01 SUPPL 14 Approval Manufacturing (CMC) N/A
2004/10/21 SUPPL 11 Approval Labeling STANDARD
2004/10/21 SUPPL 10 Approval Labeling STANDARD
2004/10/21 SUPPL 2 Approval Labeling STANDARD
2002/10/30 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2002/04/10 SUPPL 7 Approval Efficacy STANDARD
2002/04/10 SUPPL 5 Approval Labeling STANDARD
2002/04/10 SUPPL 4 Approval Labeling STANDARD
2001/12/08 SUPPL 3 Approval Labeling STANDARD
2000/07/18 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1998/11/03 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1997/12/19 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 5547957 2013/10/15 U-236 PDF格式**本条是由Drugfuture回溯的历史信息**
5571817 2013/11/05 U-259 PDF格式**本条是由Drugfuture回溯的历史信息**
5886184 2012/11/19 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
与本品治疗等效的药品
活性成分:FINASTERIDE 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
020788 001 NDA PROPECIA FINASTERIDE TABLET;ORAL 1MG Prescription Yes Yes AB 1997/12/19 MERCK
076436 001 ANDA FINASTERIDE FINASTERIDE TABLET;ORAL 1MG Prescription No No AB 2006/07/28 DR REDDYS LABS INC
090060 001 ANDA FINASTERIDE FINASTERIDE TABLET;ORAL 1MG Prescription No No AB 2013/07/01 HETERO LABS LTD III
090508 001 ANDA FINASTERIDE FINASTERIDE TABLET;ORAL 1MG Prescription No No AB 2013/07/01 SUN PHARM
091643 001 ANDA FINASTERIDE FINASTERIDE TABLET;ORAL 1MG Prescription No No AB 2013/11/05 ACCORD HLTHCARE
203687 001 ANDA FINASTERIDE FINASTERIDE TABLET;ORAL 1MG Prescription No No AB 2013/11/05 AUROBINDO PHARMA LTD
078371 001 ANDA FINASTERIDE FINASTERIDE TABLET;ORAL 1MG Prescription No No AB 2013/11/05 ACTAVIS TOTOWA
077335 001 ANDA FINASTERIDE FINASTERIDE TABLET;ORAL 1MG Prescription No No AB 2014/11/20 CIPLA
207750 001 ANDA FINASTERIDE FINASTERIDE TABLET;ORAL 1MG Prescription No No AB 2017/01/06 ALKEM LABS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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