药品注册申请号：075113
申请类型：ANDA (仿制药申请)
申请人：SANDOZ
申请人全名：SANDOZ 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 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG No No AB 1998/08/04 1998/08/04 Prescription
002 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG No Yes AB 1998/08/04 Prescription
003 LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG No No AB 1998/08/04 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
2015/11/25 SUPPL-28（补充） Approval Labeling STANDARD
2010/09/28 SUPPL-16（补充） Approval Labeling
2002/12/20 SUPPL-6（补充） Approval Manufacturing (CMC)
2002/12/20 SUPPL-5（补充） Approval Manufacturing (CMC)
2001/11/29 SUPPL-4（补充） Approval Manufacturing (CMC)
2001/11/29 SUPPL-3（补充） Approval Manufacturing (CMC)
2000/02/02 SUPPL-2（补充） Approval Manufacturing (CMC)
1999/04/30 SUPPL-1（补充） Approval Labeling
1998/08/04 ORIG-1（原始申请） Approval
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
无
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:LABETALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 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
075133 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1998/08/03 WATSON LABS
074787 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1998/08/03 HERITAGE PHARMA
075113 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1998/08/04 SANDOZ
075215 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 1999/07/29 ANDAS 5 HOLDING
200908 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2012/07/10 ENDO OPERATIONS
207743 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2017/09/19 ZYDUS PHARMS
209603 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2018/06/20 APPCO
207863 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2019/02/04 HIBROW HLTHCARE
211325 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2019/05/13 CADILA PHARMS LTD
212990 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2020/09/30 EPIC PHARMA LLC
211953 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Prescription No No AB 2021/08/18 RUBICON
212719 001 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 100MG Discontinued No No AB 2022/08/08 UNICHEM
活性成分:LABETALOL HYDROCHLORIDE 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
075133 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 1998/08/03 WATSON LABS
074787 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 1998/08/03 HERITAGE PHARMA
075113 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No Yes AB 1998/08/04 SANDOZ
075215 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 1999/07/29 ANDAS 5 HOLDING
200908 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No Yes AB 2012/07/10 ENDO OPERATIONS
207743 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2017/09/19 ZYDUS PHARMS
209603 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2018/06/20 APPCO
207863 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2019/02/04 HIBROW HLTHCARE
211325 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2019/05/13 CADILA PHARMS LTD
212990 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2020/09/30 EPIC PHARMA LLC
211953 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Prescription No No AB 2021/08/18 RUBICON
212719 002 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 200MG Discontinued No No AB 2022/08/08 UNICHEM
活性成分:LABETALOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:300MG 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
075133 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 1998/08/03 WATSON LABS
074787 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 1998/08/03 HERITAGE PHARMA
075113 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 1998/08/04 SANDOZ
075215 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 1999/07/29 ANDAS 5 HOLDING
200908 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2012/07/10 ENDO OPERATIONS
207743 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2017/09/19 ZYDUS PHARMS
209603 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2018/06/20 APPCO
207863 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2019/02/04 HIBROW HLTHCARE
211325 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2019/05/13 CADILA PHARMS LTD
212990 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2020/09/30 EPIC PHARMA LLC
211953 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Prescription No No AB 2021/08/18 RUBICON
212719 003 ANDA LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE TABLET;ORAL 300MG Discontinued No No AB 2022/08/08 UNICHEM
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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