药品注册申请号:018760
申请类型:NDA (新药申请)
申请人:TWI PHARMS
申请人全名:TWI PHARMACEUTICALS 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 TENORETIC 100 ATENOLOL; CHLORTHALIDONE TABLET;ORAL 100MG;25MG Yes Yes AB 1984/06/08 1984/06/08 Prescription
002 TENORETIC 50 ATENOLOL; CHLORTHALIDONE TABLET;ORAL 50MG;25MG Yes No AB 1984/06/08 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
2023/12/22 SUPPL-44(补充) Approval Labeling STANDARD
2012/10/31 SUPPL-29(补充) Approval Labeling UNKNOWN
2011/08/21 SUPPL-28(补充) Approval Labeling UNKNOWN
2008/10/29 SUPPL-27(补充) Approval Labeling STANDARD
2005/02/09 SUPPL-26(补充) Approval Labeling STANDARD
2003/10/30 SUPPL-25(补充) Approval Labeling STANDARD
2003/01/31 SUPPL-24(补充) Approval Labeling STANDARD
2000/04/04 SUPPL-22(补充) Approval Labeling STANDARD
1999/07/21 SUPPL-23(补充) Approval Labeling STANDARD
1996/10/11 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1996/02/09 SUPPL-20(补充) Approval Labeling STANDARD
1994/05/04 SUPPL-18(补充) Approval Labeling STANDARD
1993/06/04 SUPPL-17(补充) Approval Labeling STANDARD
1993/04/29 SUPPL-16(补充) Approval Labeling STANDARD
1992/08/05 SUPPL-15(补充) Approval Labeling
1992/08/05 SUPPL-14(补充) Approval Labeling
1991/09/18 SUPPL-13(补充) Approval Labeling
1991/04/26 SUPPL-12(补充) Approval Labeling
1991/04/26 SUPPL-11(补充) Approval Labeling
1991/04/26 SUPPL-10(补充) Approval Labeling
1987/01/08 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1985/09/20 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1985/08/19 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1985/06/17 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1985/01/08 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1984/11/19 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1984/11/06 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1984/08/20 SUPPL-2(补充) Approval Labeling
1984/08/13 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1984/06/08 ORIG-1(原始申请) Approval Type 4 - New Combination 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
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:ATENOLOL; CHLORTHALIDONE 剂型/给药途径:TABLET;ORAL 规格:100MG;25MG 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
018760 001 NDA TENORETIC 100 ATENOLOL; CHLORTHALIDONE TABLET;ORAL 100MG;25MG Prescription Yes Yes AB 1984/06/08 TWI PHARMS
072302 001 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 100MG;25MG Prescription No No AB 1990/05/31 TWI PHARMS
073665 002 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 100MG;25MG Prescription No No AB 1992/07/02 WATSON LABS
210028 002 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 100MG;25MG Prescription No No AB 2019/03/08 ZYDUS PHARMS
213302 002 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 100MG;25MG Prescription No No AB 2020/11/25 UNICHEM
215560 002 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 100MG;25MG Prescription No No AB 2021/10/25 NOVITIUM PHARMA
活性成分:ATENOLOL; CHLORTHALIDONE 剂型/给药途径:TABLET;ORAL 规格:50MG;25MG 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
018760 002 NDA TENORETIC 50 ATENOLOL; CHLORTHALIDONE TABLET;ORAL 50MG;25MG Prescription Yes No AB 1984/06/08 TWI PHARMS
072302 002 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 50MG;25MG Prescription No No AB 1990/05/31 TWI PHARMS
073665 001 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 50MG;25MG Prescription No No AB 1992/07/02 WATSON LABS
210028 001 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 50MG;25MG Prescription No No AB 2019/03/08 ZYDUS PHARMS
213302 001 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 50MG;25MG Prescription No No AB 2020/11/25 UNICHEM
215560 001 ANDA ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE TABLET;ORAL 50MG;25MG Prescription No No AB 2021/10/25 NOVITIUM PHARMA
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