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
2023/09/13 SUPPL-54（补充） Approval Labeling STANDARD
2018/03/20 SUPPL-47（补充） Approval Labeling STANDARD
2015/08/28 SUPPL-26（补充） Approval Labeling STANDARD
2014/09/16 SUPPL-30（补充） Approval Labeling STANDARD
2014/01/16 SUPPL-35（补充） Approval Labeling UNKNOWN
2013/07/29 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
2013/03/06 SUPPL-38（补充） Approval Labeling STANDARD
2012/12/11 SUPPL-40（补充） Approval Labeling STANDARD
2011/10/30 SUPPL-39（补充） Approval REMS N/A
2011/03/03 SUPPL-33（补充） Approval Labeling STANDARD
2011/03/03 SUPPL-31（补充） Approval Labeling STANDARD
2009/04/23 SUPPL-32（补充） Approval Labeling 901 REQUIRED
2007/12/11 SUPPL-28（补充） Approval Labeling STANDARD
2007/08/16 SUPPL-25（补充） Approval Labeling STANDARD
2002/05/06 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
2002/01/28 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
2001/11/15 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
2001/03/07 SUPPL-17（补充） Approval Labeling STANDARD
2001/02/22 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2001/01/11 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
2000/04/11 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
2000/04/10 SUPPL-14（补充） Approval Labeling STANDARD
2000/04/10 SUPPL-7（补充） Approval Labeling STANDARD
2000/03/07 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
2000/02/14 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1999/06/29 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1999/04/22 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1999/01/04 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1998/09/17 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1998/07/15 SUPPL-8（补充） Approval Labeling STANDARD
1998/07/15 SUPPL-6（补充） Approval Labeling STANDARD
1998/07/15 SUPPL-5（补充） Approval Labeling STANDARD
1998/07/15 SUPPL-2（补充） Approval Labeling STANDARD
1996/09/24 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
1996/07/26 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1996/06/24 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1996/03/25 ORIG-1（原始申请） 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
无
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
211623 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2020/04/24 UNIQUE PHARM
213311 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2021/04/13 CSPC OUYI
212948 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2021/09/30 ANBISON LAB
215591 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2022/03/31 ZHEJIANG JIUZHOU
216594 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2022/08/18 UMEDICA
216404 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2022/12/02 NOVAST LABS
216235 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2023/03/02 EPIC PHARMA LLC
212704 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Discontinued No No AB 2023/09/22 AMNEAL PHARMS
213159 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Discontinued No No AB 2024/03/08 APOTEX
215664 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2024/10/22 OSMOTICA PHARM US
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
211623 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2020/04/24 UNIQUE PHARM
213311 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2021/04/13 CSPC OUYI
212948 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2021/09/30 ANBISON LAB
215591 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2022/03/31 ZHEJIANG JIUZHOU
216594 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2022/08/18 UMEDICA
216404 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2022/12/02 NOVAST LABS
216235 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2023/03/02 EPIC PHARMA LLC
212704 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB 2023/09/22 AMNEAL PHARMS
213159 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Discontinued No No AB 2024/03/08 APOTEX
215664 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2024/10/22 OSMOTICA PHARM US
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
211623 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2020/04/24 UNIQUE PHARM
213311 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2021/04/13 CSPC OUYI
212948 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2021/09/30 ANBISON LAB
215591 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2022/03/31 ZHEJIANG JIUZHOU
216594 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2022/08/18 UMEDICA
216404 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2022/12/02 NOVAST LABS
216235 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2023/03/02 EPIC PHARMA LLC
212704 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Discontinued No No AB 2023/09/22 AMNEAL PHARMS
213159 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Discontinued No No AB 2024/03/08 APOTEX
215664 003 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET, EXTENDED RELEASE;ORAL 400MG Prescription No No AB 2024/10/22 OSMOTICA PHARM US
更多信息
药品NDC数据与药品包装、标签说明书
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