药品注册申请号:020234
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS PHARMACEUTICALS CORP
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 TEGRETOL-XR CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Yes No AB 1996/03/25 1996/03/25 Prescription
002 TEGRETOL-XR CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Yes No AB 1996/03/25 Prescription
003 TEGRETOL-XR CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Yes Yes AB 1996/03/25 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
2018/03/20 SUPPL 47 Approval Labeling STANDARD
2015/08/28 SUPPL 26 Approval Labeling STANDARD
2014/09/16 SUPPL 30 Approval Labeling STANDARD
2014/01/16 SUPPL 35 Approval Labeling UNKNOWN
2013/07/29 SUPPL 41 Approval Manufacturing (CMC) STANDARD
2013/03/06 SUPPL 38 Approval Labeling STANDARD
2012/12/11 SUPPL 40 Approval Labeling STANDARD
2011/10/30 SUPPL 39 Approval REMS N/A
2011/03/03 SUPPL 33 Approval Labeling STANDARD
2011/03/03 SUPPL 31 Approval Labeling STANDARD
2009/04/23 SUPPL 32 Approval Labeling 901 REQUIRED
2007/12/11 SUPPL 28 Approval Labeling STANDARD
2007/08/16 SUPPL 25 Approval Labeling STANDARD
2002/05/06 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2002/01/28 SUPPL 22 Approval Manufacturing (CMC) STANDARD
2001/11/15 SUPPL 20 Approval Manufacturing (CMC) STANDARD
2001/03/07 SUPPL 17 Approval Labeling STANDARD
2001/02/22 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2001/01/11 SUPPL 18 Approval Manufacturing (CMC) STANDARD
2000/04/11 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2000/04/10 SUPPL 14 Approval Labeling STANDARD
2000/04/10 SUPPL 7 Approval Labeling STANDARD
2000/03/07 SUPPL 15 Approval Manufacturing (CMC) STANDARD
2000/02/14 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1999/06/29 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1999/04/22 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1999/01/04 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1998/09/17 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1998/07/15 SUPPL 8 Approval Labeling STANDARD
1998/07/15 SUPPL 6 Approval Labeling STANDARD
1998/07/15 SUPPL 5 Approval Labeling STANDARD
1998/07/15 SUPPL 2 Approval Labeling STANDARD
1996/09/24 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1996/07/26 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1996/06/24 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1996/03/25 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 5284662 2011/02/08 PDF格式**本条是由Drugfuture回溯的历史信息**
RE34990 2007/07/29 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5284662 2011/02/08 PDF格式**本条是由Drugfuture回溯的历史信息**
RE34990 2007/07/29 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5284662 2011/02/08 PDF格式**本条是由Drugfuture回溯的历史信息**
RE34990 2007/07/29 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:CARBAMAZEPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:100MG 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
020234 001 NDA TEGRETOL-XR CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription Yes No AB 1996/03/25 NOVARTIS
078115 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2009/03/31 TARO
205571 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2019/02/07 ZYDUS PHARMS
活性成分:CARBAMAZEPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:200MG 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
020234 002 NDA TEGRETOL-XR CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription Yes No AB 1996/03/25 NOVARTIS
078115 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2009/03/31 TARO
205571 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2019/02/07 ZYDUS PHARMS
活性成分:CARBAMAZEPINE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:400MG 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
020234 003 NDA TEGRETOL-XR CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription Yes Yes AB 1996/03/25 NOVARTIS
078115 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2009/03/31 TARO
205571 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2019/02/07 ZYDUS PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2019 DrugFuture->U.S. FDA Drugs Database