药品注册申请号:020051
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER 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 GLYNASE GLYBURIDE TABLET;ORAL 1.5MG Yes No AB 1992/03/04 1992/03/04 Prescription
002 GLYNASE GLYBURIDE TABLET;ORAL 3MG Yes No AB 1992/03/04 Prescription
003 GLYNASE GLYBURIDE TABLET;ORAL 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1993/09/24 Discontinued
004 GLYNASE GLYBURIDE TABLET;ORAL 6MG Yes Yes AB 1993/09/24 Prescription
批准日期,审批历史,通知信,药品说明书,审评文件等信息
审批结论日期申请类型申请提交号审批结论申请内容分类审评分类(优先级;罕用药状态)通知信、审评文件、说明书、包装标签备注
2017/08/22 SUPPL 22 Approval Labeling STANDARD
2015/05/22 SUPPL 21 Approval Labeling STANDARD
2013/10/15 SUPPL 20 Approval Labeling STANDARD
2011/02/07 SUPPL 17 Approval Labeling UNKNOWN
2009/08/27 SUPPL 16 Approval Labeling STANDARD
2008/10/29 SUPPL 13 Approval Labeling STANDARD
1999/11/30 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1999/10/28 SUPPL 9 Approval Labeling STANDARD
1997/04/18 SUPPL 7 Approval Labeling STANDARD
1997/01/10 SUPPL 8 Approval Labeling STANDARD
1996/02/21 SUPPL 4 Approval Labeling STANDARD
1993/09/24 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1993/01/21 SUPPL 3 Approval Labeling STANDARD
1992/06/08 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1992/03/04 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 4735805 2007/03/11 PDF格式**本条是由Drugfuture回溯的历史信息**
4916163 2007/04/10 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4735805 2007/03/11 PDF格式**本条是由Drugfuture回溯的历史信息**
4916163 2007/04/10 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4735805 2007/03/11 PDF格式**本条是由Drugfuture回溯的历史信息**
4916163 2007/04/10 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4735805 2007/03/11 PDF格式**本条是由Drugfuture回溯的历史信息**
4916163 2007/04/10 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:GLYBURIDE 剂型/给药途径:TABLET;ORAL 规格:1.5MG 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
020051 001 NDA GLYNASE GLYBURIDE TABLET;ORAL 1.5MG Prescription Yes No AB 1992/03/04 PFIZER
074686 001 ANDA GLYBURIDE (MICRONIZED) GLYBURIDE TABLET;ORAL 1.5MG Prescription No No AB 1999/04/20 TEVA
075890 001 ANDA GLYBURIDE (MICRONIZED) GLYBURIDE TABLET;ORAL 1.5MG Prescription No No AB 2003/07/31 HIKMA
活性成分:GLYBURIDE 剂型/给药途径:TABLET;ORAL 规格:3MG 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
020051 002 NDA GLYNASE GLYBURIDE TABLET;ORAL 3MG Prescription Yes No AB 1992/03/04 PFIZER
074686 002 ANDA GLYBURIDE (MICRONIZED) GLYBURIDE TABLET;ORAL 3MG Prescription No No AB 1999/04/20 TEVA
075890 002 ANDA GLYBURIDE (MICRONIZED) GLYBURIDE TABLET;ORAL 3MG Prescription No No AB 2003/07/31 HIKMA
活性成分:GLYBURIDE 剂型/给药途径:TABLET;ORAL 规格:6MG 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
020051 004 NDA GLYNASE GLYBURIDE TABLET;ORAL 6MG Prescription Yes Yes AB 1993/09/24 PFIZER
074686 004 ANDA GLYBURIDE (MICRONIZED) GLYBURIDE TABLET;ORAL 6MG Prescription No No AB 1999/04/20 TEVA
075890 003 ANDA GLYBURIDE (MICRONIZED) GLYBURIDE TABLET;ORAL 6MG Prescription No No AB 2003/07/31 HIKMA
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2022 DrugFuture->U.S. FDA Drugs Database