药品注册申请号：218789
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA LTD
申请人全名：AUROBINDO PHARMA LTD
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 HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG No No AB 2024/04/19 2024/04/19 Prescription
002 HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG No No AB 2024/04/19 Prescription
003 HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG No No AB 2024/04/19 Prescription
004 HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG No No AB 2024/04/19 Prescription
005 HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG No No AB 2024/04/19 Prescription
006 HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG No No AB 2024/04/19 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
2024/04/19 ORIG-1（原始申请） Approval 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
2025/01/22 SUPPL-1（补充） Approval Labeling-Package Insert 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
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:HALOPERIDOL; 剂型/给药途径:TABLET;ORAL; 规格:0.5MG; 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
071206 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB -- SANDOZ
070278 006 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB 1986/06/10 MYLAN
071209 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB 1986/11/17 CHARTWELL RX
071173 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB 1987/01/02 INNOGENIX
211061 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB 2020/01/08 APPCO
200854 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Discontinued No No AB 2022/07/01 ACTAVIS GROUP
216004 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB 2022/11/18 MSN
077580 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB 2023/01/17 ZYDUS PHARMS USA
216918 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB 2024/04/11 MANKIND PHARMA
218789 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 0.5MG Prescription No No AB 2024/04/19 AUROBINDO PHARMA LTD
>>>活性成分:HALOPERIDOL; 剂型/给药途径:TABLET;ORAL; 规格:1MG; 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
071207 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB -- SANDOZ
070278 004 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB 1986/06/10 MYLAN
071209 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB 1986/11/17 CHARTWELL RX
071173 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB 1987/01/02 INNOGENIX
211061 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB 2020/01/08 APPCO
200854 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Discontinued No No AB 2022/07/01 ACTAVIS GROUP
216004 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB 2022/11/18 MSN
077580 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB 2023/01/17 ZYDUS PHARMS USA
216918 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB 2024/04/11 MANKIND PHARMA
218789 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 1MG Prescription No No AB 2024/04/19 AUROBINDO PHARMA LTD
>>>活性成分:HALOPERIDOL; 剂型/给药途径:TABLET;ORAL; 规格:2MG; 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
070278 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Prescription No Yes AB 1986/06/10 MYLAN
071173 004 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Prescription No No AB 1987/01/02 INNOGENIX
071130 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Prescription No No AB 1987/02/17 AIPING PHARM INC
211061 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Prescription No No AB 2020/01/08 APPCO
200854 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Discontinued No No AB 2022/07/01 ACTAVIS GROUP
216004 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Prescription No No AB 2022/11/18 MSN
077580 006 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Prescription No No AB 2023/01/17 ZYDUS PHARMS USA
216918 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Prescription No No AB 2024/04/11 MANKIND PHARMA
218789 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 2MG Prescription No No AB 2024/04/19 AUROBINDO PHARMA LTD
>>>活性成分:HALOPERIDOL; 剂型/给药途径:TABLET;ORAL; 规格:5MG; 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
070278 005 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 1986/06/10 MYLAN
071209 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 1986/11/17 CHARTWELL RX
071130 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 1987/02/17 AIPING PHARM INC
071173 005 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 1988/01/07 INNOGENIX
077580 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 2007/11/29 ZYDUS PHARMS USA
211061 004 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 2020/01/08 APPCO
200854 004 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Discontinued No No AB 2022/07/01 ACTAVIS GROUP
216004 004 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 2022/11/18 MSN
216918 004 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 2024/04/11 MANKIND PHARMA
218789 004 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 5MG Prescription No No AB 2024/04/19 AUROBINDO PHARMA LTD
>>>活性成分:HALOPERIDOL; 剂型/给药途径:TABLET;ORAL; 规格:10MG; 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
071130 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 1987/05/12 AIPING PHARM INC
071173 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 1988/01/07 INNOGENIX
071210 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 1988/03/11 CHARTWELL RX
077580 004 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 2007/11/29 ZYDUS PHARMS USA
070278 002 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 2009/07/16 MYLAN
211061 005 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 2020/01/08 APPCO
200854 005 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Discontinued No No AB 2022/07/01 ACTAVIS GROUP
216004 005 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 2022/11/18 MSN
216918 005 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 2024/04/11 MANKIND PHARMA
218789 005 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 10MG Prescription No No AB 2024/04/19 AUROBINDO PHARMA LTD
>>>活性成分:HALOPERIDOL; 剂型/给药途径:TABLET;ORAL; 规格:20MG; 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
071173 006 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Prescription No No AB 1988/01/07 INNOGENIX
071211 001 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Prescription No No AB 1988/03/11 CHARTWELL RX
077580 005 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Prescription No No AB 2007/11/29 ZYDUS PHARMS USA
070278 003 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Prescription No No AB 2009/07/16 MYLAN
211061 006 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Prescription No No AB 2020/01/08 APPCO
200854 006 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Discontinued No No AB 2022/07/01 ACTAVIS GROUP
216004 006 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Prescription No No AB 2022/11/18 MSN
216918 006 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Prescription No No AB 2024/04/11 MANKIND PHARMA
218789 006 ANDA HALOPERIDOL HALOPERIDOL TABLET;ORAL 20MG Prescription No No AB 2024/04/19 AUROBINDO PHARMA LTD
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药品NDC数据与药品包装、标签说明书
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