药品注册申请号:018602
申请类型:NDA (新药申请)
申请人:BAUSCH
申请人全名:BAUSCH HEALTH US LLC
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 CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG Yes No AB 1982/11/05 1982/11/05 Prescription
002 CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG Yes No AB 1982/11/05 Prescription
003 CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG Yes No AB 1986/12/08 Prescription
004 CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG Yes Yes AB 1986/12/08 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
2020/06/29 SUPPL-69(补充) Approval Manufacturing (CMC) N/A
2016/11/18 SUPPL-67(补充) Approval Labeling STANDARD
2014/11/21 SUPPL-65(补充) Approval Labeling STANDARD
2014/06/24 SUPPL-64(补充) Approval Manufacturing (CMC) STANDARD
2010/11/23 SUPPL-63(补充) Approval Labeling UNKNOWN
2003/03/21 SUPPL-56(补充) Approval Labeling STANDARD
2001/06/04 SUPPL-58(补充) Approval Manufacturing (CMC) STANDARD
1999/06/18 SUPPL-57(补充) Approval Manufacturing (CMC) STANDARD
1998/02/05 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
1997/11/19 SUPPL-54(补充) Approval Manufacturing (CMC) STANDARD
1997/08/04 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
1996/04/02 SUPPL-51(补充) Approval Labeling STANDARD
1996/04/02 SUPPL-50(补充) Approval Labeling STANDARD
1995/08/29 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
1995/05/04 SUPPL-46(补充) Approval Manufacturing (CMC) STANDARD
1994/12/30 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1994/12/28 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1994/11/29 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1994/10/12 SUPPL-40(补充) Approval Labeling
1994/09/21 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
1993/07/07 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1993/07/01 SUPPL-23(补充) Approval Efficacy
1993/04/13 SUPPL-41(补充) Approval Manufacturing (CMC) STANDARD
1993/02/08 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
1992/05/27 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
1991/06/13 SUPPL-38(补充) Approval Labeling
1991/03/14 SUPPL-37(补充) Approval Manufacturing (CMC) STANDARD
1990/04/12 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
1989/12/18 SUPPL-36(补充) Approval Manufacturing (CMC) STANDARD
1989/11/21 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1988/12/14 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1988/10/13 SUPPL-32(补充) Approval Labeling
1988/08/12 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1988/02/19 SUPPL-29(补充) Approval Manufacturing (CMC) STANDARD
1988/02/19 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1987/12/07 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1987/11/30 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1987/10/29 SUPPL-25(补充) Approval Labeling
1986/12/08 SUPPL-20(补充) Approval Efficacy
1986/07/28 SUPPL-22(补充) Approval Labeling
1986/07/28 SUPPL-11(补充) Approval Efficacy
1985/06/20 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1985/02/04 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1984/06/08 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1984/06/08 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1984/02/28 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1983/10/06 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1983/10/06 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1983/09/06 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1983/05/27 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1983/05/27 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1983/03/11 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1983/03/11 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1982/11/05 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:30MG 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
018602 001 NDA CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG Prescription Yes No AB 1982/11/05 BAUSCH
074185 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 1995/05/31 TEVA
211596 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG Discontinued No No AB 2019/11/18 EDENBRIDGE PHARMS
216521 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2022/09/23 SCIEGEN PHARMS INC
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:60MG 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
018602 002 NDA CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG Prescription Yes No AB 1982/11/05 BAUSCH
074185 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 1995/05/31 TEVA
211596 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG Discontinued No No AB 2019/11/18 EDENBRIDGE PHARMS
216521 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2022/09/23 SCIEGEN PHARMS INC
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:90MG 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
018602 003 NDA CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG Prescription Yes No AB 1986/12/08 BAUSCH
074185 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG Prescription No No AB 1995/05/31 TEVA
211596 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG Discontinued No No AB 2019/11/18 EDENBRIDGE PHARMS
216521 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 90MG Prescription No No AB 2022/09/23 SCIEGEN PHARMS INC
活性成分:DILTIAZEM HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:120MG 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
018602 004 NDA CARDIZEM DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG Prescription Yes Yes AB 1986/12/08 BAUSCH
074185 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 1995/05/31 TEVA
211596 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG Discontinued No No AB 2019/11/18 EDENBRIDGE PHARMS
216521 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE TABLET;ORAL 120MG Prescription No No AB 2022/09/23 SCIEGEN PHARMS INC
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