药品注册申请号：020062
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 CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Yes No AB3 1991/12/27 1992/08/10 Prescription
002 CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Yes No AB3 1991/12/27 Prescription
003 CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Yes No AB3 1991/12/27 Prescription
004 CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Yes No AB3 1991/12/27 Prescription
005 CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Yes Yes AB3 1999/08/24 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1991/12/27 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/04/16 SUPPL-48（补充） Approval Labeling-Package Insert STANDARD
2020/03/26 SUPPL-46（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2017/01/23 SUPPL-44（补充） Approval Manufacturing (CMC) STANDARD
2016/11/18 SUPPL-43（补充） Approval Labeling-Package Insert STANDARD
2016/06/29 SUPPL-42（补充） Approval Labeling-Container/Carton Labels STANDARD
2010/11/22 SUPPL-40（补充） Approval Labeling-Package Insert UNKNOWN
2003/03/21 SUPPL-25（补充） Approval Labeling STANDARD
2001/06/04 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/01/21 SUPPL-32（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/12/03 SUPPL-31（补充） Approval Manufacturing (CMC) STANDARD
1999/11/18 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
1999/10/19 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/08/24 SUPPL-27（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1999/04/29 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/04/15 SUPPL-26（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/04/07 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/11/21 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1997/08/06 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1996/04/02 SUPPL-21（补充） Approval Labeling STANDARD
1996/04/02 SUPPL-19（补充） Approval Labeling STANDARD
1995/10/31 SUPPL-18（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/09/25 SUPPL-13（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1995/05/11 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/05/04 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/04/03 SUPPL-10（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1994/11/22 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/10/24 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/09/28 SUPPL-12（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1994/09/14 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1994/05/05 SUPPL-9（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/11/01 SUPPL-8（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/10/06 SUPPL-7（补充） Approval Labeling STANDARD
1993/06/29 SUPPL-6（补充） Approval Manufacturing (CMC)-Control STANDARD
1993/04/28 SUPPL-5（补充） Approval Labeling STANDARD
1992/10/15 SUPPL-1（补充） Approval Efficacy-New Indication
1992/09/18 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1992/08/10 SUPPL-3（补充） Approval Efficacy-New Dosing Regimen
1992/08/04 SUPPL-2（补充） Approval Manufacturing (CMC) 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 4894240 2007/01/16 PDF格式**本条是由Drugfuture回溯的历史信息**
5002776 2008/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
5286497 2011/05/20 PDF格式**本条是由Drugfuture回溯的历史信息**
5364620 2011/11/14 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5439689 2012/08/08 U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
5470584 2011/05/20 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4894240 2007/01/16 PDF格式**本条是由Drugfuture回溯的历史信息**
5002776 2008/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
5286497 2011/05/20 PDF格式**本条是由Drugfuture回溯的历史信息**
5364620 2011/11/14 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5439689 2012/08/08 U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
5470584 2011/05/20 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4894240 2007/01/16 PDF格式**本条是由Drugfuture回溯的历史信息**
5002776 2008/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
5286497 2011/05/20 PDF格式**本条是由Drugfuture回溯的历史信息**
5364620 2011/11/14 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5439689 2012/08/08 U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
5470584 2011/05/20 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4894240 2007/01/16 PDF格式**本条是由Drugfuture回溯的历史信息**
5002776 2008/03/26 PDF格式**本条是由Drugfuture回溯的历史信息**
5286497 2011/05/20 PDF格式**本条是由Drugfuture回溯的历史信息**
5364620 2011/11/14 U-3 PDF格式**本条是由Drugfuture回溯的历史信息**
5439689 2012/08/08 U-107 PDF格式**本条是由Drugfuture回溯的历史信息**
5470584 2011/05/20 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:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:120MG; 治疗等效代码:AB3<<<
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
020062 001 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription Yes No AB3 1992/08/10 BAUSCH
074752 002 ANDA CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 1998/07/09 ACTAVIS LABS FL INC
074984 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 1999/12/20 PH HEALTH
075116 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 1999/12/23 VALEANT PHARMS NORTH
090492 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Discontinued No No AB3 2011/10/28 SUN PHARM
203023 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Discontinued No No AB3 2017/06/08 SUN PHARM
206534 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB3 2024/11/08 ALEMBIC
>>>活性成分:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:180MG; 治疗等效代码:AB3<<<
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
020062 002 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription Yes No AB3 1991/12/27 BAUSCH
074752 001 ANDA CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 1998/07/09 ACTAVIS LABS FL INC
074984 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 1999/12/20 PH HEALTH
075116 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 1999/12/23 VALEANT PHARMS NORTH
090492 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Discontinued No No AB3 2011/10/28 SUN PHARM
203023 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Discontinued No No AB3 2017/06/08 SUN PHARM
206534 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB3 2024/11/08 ALEMBIC
>>>活性成分:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:240MG; 治疗等效代码:AB3<<<
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
020062 003 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription Yes No AB3 1991/12/27 BAUSCH
074752 003 ANDA CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 1998/07/09 ACTAVIS LABS FL INC
074984 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 1999/12/20 PH HEALTH
075116 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 1999/12/23 VALEANT PHARMS NORTH
090492 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Discontinued No No AB3 2011/10/28 SUN PHARM
203023 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Discontinued No No AB3 2017/06/08 SUN PHARM
206534 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB3 2024/11/08 ALEMBIC
>>>活性成分:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:300MG; 治疗等效代码:AB3<<<
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
020062 004 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription Yes No AB3 1991/12/27 BAUSCH
074752 004 ANDA CARTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 1998/07/09 ACTAVIS LABS FL INC
074984 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 1999/12/20 PH HEALTH
075116 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 1999/12/23 VALEANT PHARMS NORTH
090492 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Discontinued No No AB3 2011/10/28 SUN PHARM
203023 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Discontinued No No AB3 2017/06/08 SUN PHARM
206534 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB3 2024/11/08 ALEMBIC
>>>活性成分:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:360MG; 治疗等效代码:AB3<<<
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
020062 005 NDA CARDIZEM CD DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription Yes Yes AB3 1999/08/24 BAUSCH
090492 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Discontinued No No AB3 2011/10/28 SUN PHARM
202463 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB3 2012/12/07 ACTAVIS ELIZABETH
203023 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB3 2017/06/08 SUN PHARM
206534 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB3 2017/08/08 ZYDUS PHARMS
205231 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB3 2018/08/30 TWI PHARMS
208783 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB3 2019/06/14 NOVAST LABS
216968 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB3 2024/11/08 ALEMBIC
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