药品注册申请号:076697
申请类型:ANDA (仿制药申请)
申请人:NOSTRUM LABS INC
申请人全名:NOSTRUM LABORATORIES 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 CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 100MG No No AB 2011/05/20 2011/05/20 Prescription
002 CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 200MG No No AB 2011/05/20 Prescription
003 CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 300MG No No AB 2011/05/20 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
2024/01/29 SUPPL-17(补充) Approval Labeling STANDARD
2022/11/09 SUPPL-16(补充) Approval Labeling STANDARD
2022/11/09 SUPPL-12(补充) Approval Labeling STANDARD
2022/11/09 SUPPL-7(补充) Approval Labeling STANDARD
2015/02/18 SUPPL-4(补充) Approval Labeling STANDARD
2011/05/20 ORIG-1(原始申请) Approval
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
与本品治疗等效的药品
活性成分:CARBAMAZEPINE 剂型/给药途径:CAPSULE, 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
020712 003 NDA CARBATROL CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription Yes No AB 1997/09/30 TAKEDA PHARMS USA
076697 001 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2011/05/20 NOSTRUM LABS INC
078986 001 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2011/11/25 APOTEX INC
078592 001 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2012/09/20 TEVA PHARMS
201106 001 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2013/06/21 TARO
活性成分:CARBAMAZEPINE 剂型/给药途径:CAPSULE, 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
020712 001 NDA CARBATROL CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription Yes No AB 1997/09/30 TAKEDA PHARMS USA
076697 002 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2011/05/20 NOSTRUM LABS INC
078986 002 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2011/11/25 APOTEX INC
078592 002 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2012/09/20 TEVA PHARMS
201106 002 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 200MG Prescription No No AB 2013/06/21 TARO
活性成分:CARBAMAZEPINE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL 规格:300MG 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
020712 002 NDA CARBATROL CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription Yes Yes AB 1997/09/30 TAKEDA PHARMS USA
076697 003 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2011/05/20 NOSTRUM LABS INC
078986 003 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2011/11/25 APOTEX INC
078592 003 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2012/09/20 TEVA PHARMS
201106 003 ANDA CARBAMAZEPINE CARBAMAZEPINE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB 2013/06/21 TARO
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