药品注册申请号:020412
申请类型:NDA (新药申请)
申请人:BRISTOL MYERS SQUIBB
申请人全名:BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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 ZERIT STAVUDINE CAPSULE;ORAL 5MG No No None 1994/06/24 1994/06/24 Discontinued
002 ZERIT STAVUDINE CAPSULE;ORAL 15MG Yes No AB 1994/06/24 Prescription
003 ZERIT STAVUDINE CAPSULE;ORAL 20MG Yes No AB 1994/06/24 Prescription
004 ZERIT STAVUDINE CAPSULE;ORAL 30MG Yes No AB 1994/06/24 Prescription
005 ZERIT STAVUDINE CAPSULE;ORAL 40MG Yes Yes AB 1994/06/24 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
2018/12/17 SUPPL 41 Approval Labeling STANDARD
2017/12/19 SUPPL 40 Approval Labeling STANDARD
2015/07/14 SUPPL 39 Approval Manufacturing (CMC) PRIORITY
2011/11/18 SUPPL 38 Approval Labeling 901 REQUIRED
2011/05/11 SUPPL 37 Approval REMS N/A
2010/12/10 SUPPL 36 Approval Labeling STANDARD
2009/07/08 SUPPL 34 Approval Labeling STANDARD
2009/02/13 SUPPL 33 Approval Labeling STANDARD
2008/12/11 SUPPL 32 Approval Labeling STANDARD
2008/04/14 SUPPL 30 Approval Labeling STANDARD
2008/04/14 SUPPL 29 Approval Labeling STANDARD
2007/06/20 SUPPL 27 Approval Labeling STANDARD
2005/12/20 SUPPL 24 Approval Labeling PRIORITY
2004/06/04 SUPPL 23 Approval Labeling STANDARD
2002/03/29 SUPPL 16 Approval Efficacy STANDARD
2002/02/20 SUPPL 18 Approval Labeling STANDARD
2002/02/20 SUPPL 17 Approval Labeling STANDARD
2001/10/16 SUPPL 15 Approval Labeling STANDARD
2001/04/17 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
2000/09/27 SUPPL 13 Approval Labeling STANDARD
1999/07/01 SUPPL 10 Approval Efficacy STANDARD
1999/06/10 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1998/09/16 SUPPL 11 Approval Labeling STANDARD
1998/08/19 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1998/02/04 SUPPL 5 Approval Labeling STANDARD
1998/02/03 SUPPL 7 Approval Manufacturing (CMC) PRIORITY
1998/01/16 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1997/09/26 SUPPL 6 Approval Manufacturing (CMC) PRIORITY
1996/09/06 SUPPL 4 Approval Efficacy PRIORITY
1996/02/09 SUPPL 3 Approval Manufacturing (CMC) PRIORITY
1995/12/21 SUPPL 2 Approval Efficacy UNKNOWN
1994/08/02 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1994/06/24 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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 4978655 2008/06/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
4978655*PED 2008/12/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4978655 2008/06/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
4978655*PED 2008/12/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4978655 2008/06/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
4978655*PED 2008/12/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4978655 2008/06/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
4978655*PED 2008/12/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
005 4978655 2008/06/24 U-94 PDF格式**本条是由Drugfuture回溯的历史信息**
4978655*PED 2008/12/24 U-94 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:STAVUDINE 剂型/给药途径:CAPSULE;ORAL 规格:15MG 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
020412 002 NDA ZERIT STAVUDINE CAPSULE;ORAL 15MG Prescription Yes No AB 1994/06/24 BRISTOL MYERS SQUIBB
077672 003 ANDA STAVUDINE STAVUDINE CAPSULE;ORAL 15MG Prescription No No AB 2008/12/29 AUROBINDO PHARMA
078957 001 ANDA STAVUDINE STAVUDINE CAPSULE;ORAL 15MG Prescription No No AB 2008/12/29 HETERO LABS LTD III
活性成分:STAVUDINE 剂型/给药途径:CAPSULE;ORAL 规格:20MG 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
020412 003 NDA ZERIT STAVUDINE CAPSULE;ORAL 20MG Prescription Yes No AB 1994/06/24 BRISTOL MYERS SQUIBB
077672 004 ANDA STAVUDINE STAVUDINE CAPSULE;ORAL 20MG Prescription No No AB 2008/12/29 AUROBINDO PHARMA
078957 002 ANDA STAVUDINE STAVUDINE CAPSULE;ORAL 20MG Prescription No No AB 2008/12/29 HETERO LABS LTD III
活性成分:STAVUDINE 剂型/给药途径:CAPSULE;ORAL 规格:30MG 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
020412 004 NDA ZERIT STAVUDINE CAPSULE;ORAL 30MG Prescription Yes No AB 1994/06/24 BRISTOL MYERS SQUIBB
077672 001 ANDA STAVUDINE STAVUDINE CAPSULE;ORAL 30MG Prescription No No AB 2008/12/29 AUROBINDO PHARMA
078957 003 ANDA STAVUDINE STAVUDINE CAPSULE;ORAL 30MG Prescription No No AB 2008/12/29 HETERO LABS LTD III
活性成分:STAVUDINE 剂型/给药途径:CAPSULE;ORAL 规格:40MG 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
020412 005 NDA ZERIT STAVUDINE CAPSULE;ORAL 40MG Prescription Yes Yes AB 1994/06/24 BRISTOL MYERS SQUIBB
077672 002 ANDA STAVUDINE STAVUDINE CAPSULE;ORAL 40MG Prescription No No AB 2008/12/29 AUROBINDO PHARMA
078957 004 ANDA STAVUDINE STAVUDINE CAPSULE;ORAL 40MG Prescription No No AB 2008/12/29 HETERO LABS LTD III
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