药品注册申请号:020496
申请类型:NDA (新药申请)
申请人:SANOFI AVENTIS US
申请人全名:SANOFI AVENTIS US LLC
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 AMARYL GLIMEPIRIDE TABLET;ORAL 1MG Yes Yes AB 1995/11/30 1995/11/30 Prescription
002 AMARYL GLIMEPIRIDE TABLET;ORAL 2MG Yes No AB 1995/11/30 Prescription
003 AMARYL GLIMEPIRIDE TABLET;ORAL 4MG Yes No AB 1995/11/30 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
2018/12/21 SUPPL-29(补充) Approval Labeling STANDARD
2016/12/19 SUPPL-28(补充) Approval Labeling STANDARD
2013/10/15 SUPPL-27(补充) Approval Labeling STANDARD
2013/08/01 SUPPL-26(补充) Approval Labeling STANDARD
2013/04/19 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
2013/03/14 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
2012/02/03 SUPPL-22(补充) Approval Labeling STANDARD
2009/06/04 SUPPL-21(补充) Approval Labeling STANDARD
2009/02/03 SUPPL-19(补充) Approval Labeling STANDARD
2009/02/03 SUPPL-18(补充) Approval Labeling STANDARD
2005/11/28 SUPPL-15(补充) Approval Efficacy PRIORITY
2005/09/19 SUPPL-16(补充) Approval Labeling STANDARD
2004/08/16 SUPPL-13(补充) Approval Labeling STANDARD
2002/04/15 SUPPL-7(补充) Approval Labeling STANDARD
2001/07/21 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
2000/12/05 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2000/09/27 SUPPL-5(补充) Approval Efficacy STANDARD
2000/08/29 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
2000/01/06 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1999/02/24 SUPPL-2(补充) Approval Efficacy STANDARD
1998/09/16 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1998/09/16 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1997/07/28 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1995/11/30 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
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-54 2008/11/28**本条是由Drugfuture回溯的历史信息**
PED 2009/05/28**本条是由Drugfuture回溯的历史信息**
002 M-54 2008/11/28**本条是由Drugfuture回溯的历史信息**
PED 2009/05/28**本条是由Drugfuture回溯的历史信息**
003 M-54 2008/11/28**本条是由Drugfuture回溯的历史信息**
PED 2009/05/28**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:GLIMEPIRIDE 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
020496 001 NDA AMARYL GLIMEPIRIDE TABLET;ORAL 1MG Prescription Yes Yes AB 1995/11/30 SANOFI AVENTIS US
077091 001 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 1MG Prescription No No AB 2005/10/06 DR REDDYS LABS LTD
077295 001 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 1MG Prescription No No AB 2005/10/06 CHARTWELL MOLECULAR
077370 001 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 1MG Prescription No No AB 2005/12/23 PRINSTON INC
078181 001 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 1MG Prescription No No AB 2007/08/23 ACCORD HLTHCARE
077911 001 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 1MG Prescription No No AB 2009/09/22 CARLSBAD
091220 001 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 1MG Prescription No No AB 2012/06/29 MICRO LABS
202759 001 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 1MG Prescription No No AB 2012/06/29 AUROBINDO PHARMA LTD
202112 001 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 1MG Prescription No No AB 2013/04/17 INDOCO REMEDIES
活性成分:GLIMEPIRIDE 剂型/给药途径:TABLET;ORAL 规格:2MG 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
020496 002 NDA AMARYL GLIMEPIRIDE TABLET;ORAL 2MG Prescription Yes No AB 1995/11/30 SANOFI AVENTIS US
077091 002 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 2MG Prescription No No AB 2005/10/06 DR REDDYS LABS LTD
077295 002 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 2MG Prescription No No AB 2005/10/06 CHARTWELL MOLECULAR
077370 002 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 2MG Prescription No No AB 2005/12/23 PRINSTON INC
078181 002 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 2MG Prescription No No AB 2007/08/23 ACCORD HLTHCARE
077911 002 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 2MG Prescription No No AB 2009/09/22 CARLSBAD
091220 002 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 2MG Prescription No No AB 2012/06/29 MICRO LABS
202759 002 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 2MG Prescription No No AB 2012/06/29 AUROBINDO PHARMA LTD
202112 002 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 2MG Prescription No No AB 2013/04/17 INDOCO REMEDIES
活性成分:GLIMEPIRIDE 剂型/给药途径:TABLET;ORAL 规格:4MG 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
020496 003 NDA AMARYL GLIMEPIRIDE TABLET;ORAL 4MG Prescription Yes No AB 1995/11/30 SANOFI AVENTIS US
077091 003 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 4MG Prescription No No AB 2005/10/06 DR REDDYS LABS LTD
077295 003 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 4MG Prescription No No AB 2005/10/06 CHARTWELL MOLECULAR
077370 003 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 4MG Prescription No No AB 2005/12/23 PRINSTON INC
078181 003 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 4MG Prescription No No AB 2007/08/23 ACCORD HLTHCARE
077911 003 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 4MG Prescription No No AB 2009/09/22 CARLSBAD
091220 004 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 4MG Prescription No No AB 2012/06/29 MICRO LABS
202759 003 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 4MG Prescription No No AB 2012/06/29 AUROBINDO PHARMA LTD
202112 003 ANDA GLIMEPIRIDE GLIMEPIRIDE TABLET;ORAL 4MG Prescription No No AB 2013/04/17 INDOCO REMEDIES
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