药品注册申请号:016608
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 CARBAMAZEPINE TABLET;ORAL 200MG Yes Yes AB 1968/03/11 Approved Prior to Jan 1, 1982 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-121(补充) Approval Labeling STANDARD
2018/03/20 SUPPL-116(补充) Approval Labeling STANDARD
2015/10/30 SUPPL-111(补充) Approval Manufacturing (CMC) PRIORITY
2015/08/28 SUPPL-97(补充) Approval Labeling STANDARD
2014/09/16 SUPPL-99(补充) Approval Labeling STANDARD
2014/01/16 SUPPL-103(补充) Approval Labeling UNKNOWN
2013/11/08 SUPPL-108(补充) Approval Manufacturing (CMC) PRIORITY
2013/03/06 SUPPL-105(补充) Approval Labeling STANDARD
2012/12/11 SUPPL-107(补充) Approval Labeling STANDARD
2011/10/30 SUPPL-106(补充) Approval REMS N/A
2011/03/03 SUPPL-102(补充) Approval Labeling STANDARD
2011/03/03 SUPPL-100(补充) Approval Labeling STANDARD
2009/04/23 SUPPL-101(补充) Approval Labeling 901 REQUIRED
2007/12/11 SUPPL-98(补充) Approval Labeling STANDARD
2007/08/16 SUPPL-96(补充) Approval Labeling STANDARD
2002/01/28 SUPPL-94(补充) Approval Manufacturing (CMC) PRIORITY
2001/11/19 SUPPL-92(补充) Approval Manufacturing (CMC) PRIORITY
2001/11/15 SUPPL-93(补充) Approval Manufacturing (CMC) PRIORITY
2001/03/07 SUPPL-90(补充) Approval Labeling STANDARD
2000/05/18 SUPPL-91(补充) Approval Manufacturing (CMC) PRIORITY
2000/04/11 SUPPL-89(补充) Approval Manufacturing (CMC) PRIORITY
2000/04/10 SUPPL-88(补充) Approval Labeling STANDARD
2000/04/10 SUPPL-84(补充) Approval Labeling STANDARD
1999/06/07 SUPPL-87(补充) Approval Manufacturing (CMC) PRIORITY
1999/04/21 SUPPL-86(补充) Approval Manufacturing (CMC) PRIORITY
1998/07/15 SUPPL-85(补充) Approval Labeling STANDARD
1998/07/15 SUPPL-83(补充) Approval Labeling STANDARD
1998/07/15 SUPPL-81(补充) Approval Labeling STANDARD
1998/07/15 SUPPL-80(补充) Approval Labeling STANDARD
1997/03/06 SUPPL-82(补充) Approval Manufacturing (CMC) PRIORITY
1995/10/11 SUPPL-59(补充) Approval Efficacy
1995/10/05 SUPPL-79(补充) Approval Manufacturing (CMC) PRIORITY
1993/10/06 SUPPL-77(补充) Approval Manufacturing (CMC) PRIORITY
1991/03/14 SUPPL-71(补充) Approval Manufacturing (CMC) PRIORITY
1990/06/01 SUPPL-70(补充) Approval Manufacturing (CMC) PRIORITY
1990/03/28 SUPPL-66(补充) Approval Manufacturing (CMC) PRIORITY
1990/03/28 SUPPL-65(补充) Approval Manufacturing (CMC) PRIORITY
1990/03/27 SUPPL-64(补充) Approval Manufacturing (CMC) PRIORITY
1990/03/26 SUPPL-68(补充) Approval Labeling
1989/07/21 SUPPL-63(补充) Approval Labeling
1989/04/07 SUPPL-62(补充) Approval Manufacturing (CMC) PRIORITY
1988/08/08 SUPPL-60(补充) Approval Manufacturing (CMC) PRIORITY
1988/08/01 SUPPL-61(补充) Approval Labeling
1987/07/31 SUPPL-58(补充) Approval Labeling
1987/07/31 SUPPL-48(补充) Approval Efficacy
1986/06/02 SUPPL-54(补充) Approval Efficacy
1986/02/03 SUPPL-56(补充) Approval Labeling
1986/01/10 SUPPL-55(补充) Approval Labeling
1986/01/10 SUPPL-53(补充) Approval Labeling
1985/05/06 SUPPL-52(补充) Approval Manufacturing (CMC) PRIORITY
1985/03/08 SUPPL-51(补充) Approval Manufacturing (CMC) PRIORITY
1984/07/31 SUPPL-50(补充) Approval Manufacturing (CMC) PRIORITY
1983/09/14 SUPPL-49(补充) Approval Manufacturing (CMC) PRIORITY
1982/07/08 SUPPL-47(补充) Approval Manufacturing (CMC) PRIORITY
1982/02/09 SUPPL-46(补充) Approval Manufacturing (CMC) PRIORITY
1981/12/08 SUPPL-45(补充) Approval Labeling
1980/03/25 SUPPL-42(补充) Approval Labeling
1980/02/01 SUPPL-43(补充) Approval Manufacturing (CMC) PRIORITY
1979/04/09 SUPPL-41(补充) Approval Manufacturing (CMC) PRIORITY
1978/11/22 SUPPL-39(补充) Approval Manufacturing (CMC) PRIORITY
1978/11/22 SUPPL-38(补充) Approval Manufacturing (CMC) PRIORITY
1978/08/09 SUPPL-37(补充) Approval Labeling
1978/08/09 SUPPL-36(补充) Approval Labeling
1977/04/04 SUPPL-35(补充) Approval Manufacturing (CMC) PRIORITY
1977/04/04 SUPPL-34(补充) Approval Manufacturing (CMC) PRIORITY
1977/04/04 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
1976/11/08 SUPPL-28(补充) Approval Labeling
1975/12/12 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
1975/12/09 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
1975/07/02 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
1975/03/31 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1975/03/28 SUPPL-23(补充) Approval Labeling
1974/12/12 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
1974/11/15 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1974/11/08 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1974/08/29 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1974/08/29 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1974/08/29 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1974/08/29 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1974/08/29 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1974/08/29 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1974/08/29 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1974/08/20 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1974/07/15 SUPPL-12(补充) Approval Labeling
1968/03/11 ORIG-1(原始申请) 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
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;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
016608 001 NDA TEGRETOL CARBAMAZEPINE TABLET;ORAL 200MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 NOVARTIS
070541 001 ANDA EPITOL CARBAMAZEPINE TABLET;ORAL 200MG Prescription No No AB 1986/09/17 TEVA
074649 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET;ORAL 200MG Prescription No No AB 1996/10/03 TARO
075948 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET;ORAL 200MG Prescription No No AB 2002/02/27 APOTEX INC
077272 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET;ORAL 200MG Prescription No No AB 2005/12/07 TORRENT PHARMS
207798 002 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET;ORAL 200MG Prescription No No AB 2020/04/15 UMEDICA
213284 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET;ORAL 200MG Prescription No No AB 2022/08/22 UNICHEM
218221 001 ANDA CARBAMAZEPINE CARBAMAZEPINE TABLET;ORAL 200MG Prescription No No AB 2024/02/16 BIONPHARMA
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药品NDC数据与药品包装、标签说明书
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