药品注册申请号：020401
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 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Yes No AB4 1995/09/11 1995/09/11 Prescription
002 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Yes No AB4 1995/09/11 Prescription
003 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Yes No AB4 1995/09/11 Prescription
004 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Yes No AB4 1995/09/11 Prescription
005 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Yes No AB4 1995/09/11 Prescription
006 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG Yes Yes AB4 1998/10/16 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
1995/09/11 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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-44（补充） Approval Labeling-Package Insert STANDARD
2016/11/18 SUPPL-42（补充） Approval Labeling-Package Insert STANDARD
2015/11/20 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
2010/11/22 SUPPL-36（补充） Approval Labeling-Package Insert UNKNOWN
2007/06/21 SUPPL-34（补充） Approval Labeling STANDARD
2002/10/03 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
2001/11/26 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
2001/09/24 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
2001/07/03 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
2000/11/29 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
2000/04/05 SUPPL-15（补充） Approval Labeling STANDARD
2000/03/24 SUPPL-19（补充） Approval Labeling STANDARD
2000/02/17 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1999/10/13 SUPPL-16（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/02/17 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1999/01/28 SUPPL-12（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/10/16 SUPPL-13（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1998/01/30 SUPPL-7（补充） Approval Efficacy-New Indication STANDARD
1997/10/01 SUPPL-6（补充） Approval Labeling STANDARD
1997/09/22 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1997/09/09 SUPPL-9（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1997/09/03 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1997/08/14 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1997/03/14 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
1996/07/23 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1996/06/26 SUPPL-5（补充） Approval Manufacturing (CMC) STANDARD
1996/05/29 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
1996/05/16 SUPPL-3（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 5529791 2013/06/25 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5529791 2013/06/25 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5529791 2013/06/25 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5529791 2013/06/25 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5529791 2013/06/25 PDF格式**本条是由Drugfuture回溯的历史信息**
006 5529791 2013/06/25 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:AB4<<<
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
020401 001 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 001 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Discontinued No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Discontinued No No AB4 2010/11/15 SUN PHARM
091022 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB4 2012/09/28 CHARTWELL RX
206641 001 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
>>>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:AB4<<<
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
020401 002 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 002 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Discontinued No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Discontinued No No AB4 2010/11/15 SUN PHARM
091022 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB4 2012/09/28 CHARTWELL RX
206641 002 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
>>>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:AB4<<<
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
020401 003 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 003 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Discontinued No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Discontinued No No AB4 2010/11/15 SUN PHARM
091022 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB4 2012/09/28 CHARTWELL RX
206641 003 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
>>>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:AB4<<<
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
020401 004 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 004 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Discontinued No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Discontinued No No AB4 2010/11/15 SUN PHARM
091022 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB4 2012/09/28 CHARTWELL RX
206641 004 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
>>>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:AB4<<<
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
020401 005 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription Yes No AB4 1995/09/11 BAUSCH
075401 005 ANDA TAZTIA XT DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Discontinued No No AB4 2003/04/10 ACTAVIS LABS FL INC
090421 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Discontinued No No AB4 2010/11/15 SUN PHARM
091022 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB4 2012/09/28 CHARTWELL RX
206641 005 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
>>>活性成分:DILTIAZEM HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:420MG; 治疗等效代码:AB4<<<
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
020401 006 NDA TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG Prescription Yes Yes AB4 1998/10/16 BAUSCH
091022 006 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG Prescription No No AB4 2012/09/28 CHARTWELL RX
206641 006 ANDA DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG Prescription No No AB4 2017/08/11 ZYDUS PHARMS
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