药品注册申请号:205241
申请类型:ANDA (仿制药申请)
申请人:GLAND PHARMA LTD
申请人全名:GLAND 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 DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML No No AO 2017/05/12 2017/05/12 Prescription
002 HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML No No AO 2017/05/12 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
2023/03/27 SUPPL-5(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-4(补充) Approval Labeling STANDARD
2019/10/29 SUPPL-2(补充) Approval Labeling STANDARD
2017/05/12 ORIG-1(原始申请) Approval 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:HALOPERIDOL DECANOATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 50MG BASE/ML 治疗等效代码:AO
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
018701 001 NDA HALDOL HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription Yes Yes AO 1986/01/14 JANSSEN PHARMS
074893 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AO 1997/12/19 FRESENIUS KABI USA
074811 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AO 1998/01/30 HIKMA
075393 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Discontinued No No AO 1999/05/11 TEVA PHARMS USA
075440 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AO 2000/02/28 MYLAN LABS LTD
205241 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AO 2017/05/12 GLAND PHARMA LTD
209101 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AO 2018/07/03 SOMERSET THERAPS LLC
211180 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AO 2019/10/22 ZYDUS PHARMS
214507 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AO 2021/07/26 MEITHEAL
216730 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 50MG BASE/ML Prescription No No AO 2023/05/23 MANKIND PHARMA
活性成分:HALOPERIDOL DECANOATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 100MG BASE/ML 治疗等效代码:AO
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
018701 002 NDA HALDOL HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription Yes Yes AO 1997/01/31 JANSSEN PHARMS
074893 002 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AO 1997/12/19 FRESENIUS KABI USA
075305 001 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AO 1998/09/28 HIKMA
075393 002 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Discontinued No No AO 1999/05/11 TEVA PHARMS USA
075440 002 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AO 2000/02/28 MYLAN LABS LTD
205241 002 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AO 2017/05/12 GLAND PHARMA LTD
209101 002 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AO 2018/07/03 SOMERSET THERAPS LLC
211180 002 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AO 2019/10/22 ZYDUS PHARMS
214507 002 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AO 2021/07/26 MEITHEAL
216730 002 ANDA HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE INJECTABLE;INJECTION EQ 100MG BASE/ML Prescription No No AO 2023/05/23 MANKIND PHARMA
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药品NDC数据与药品包装、标签说明书
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