药品注册申请号：201451
申请类型：ANDA (仿制药申请)
申请人：AMNEAL PHARMS
申请人全名：AMNEAL PHARMACEUTICALS OF NEW YORK 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 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No Yes AA 2011/02/23 2011/02/23 Prescription
002 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG No Yes AA 2011/02/23 Prescription
003 MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 50MG No No AA 2011/02/23 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
2023/09/22 SUPPL-8（补充） Approval Labeling STANDARD
2023/09/22 SUPPL-7（补充） Approval Labeling STANDARD
2023/09/22 SUPPL-6（补充） Approval Labeling STANDARD
2013/08/15 SUPPL-2（补充） Approval Labeling STANDARD
2011/02/23 ORIG-1（原始申请） Approval Not Applicable
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:MECLIZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:12.5MG 治疗等效代码:AA
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
010721 006 NDA ANTIVERT MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription Yes No AA Approved Prior to Jan 1, 1982 CASPER PHARMA LLC
084657 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Discontinued No No AA Approved Prior to Jan 1, 1982 ANI PHARMS
087128 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription No No AA Approved Prior to Jan 1, 1982 APNAR PHARMA LP
084843 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription No No AA 1989/05/22 SANDOZ
040659 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription No No AA 2010/06/04 JUBILANT CADISTA
201451 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription No Yes AA 2011/02/23 AMNEAL PHARMS
200294 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription No No AA 2012/04/13 EPIC PHARMA LLC
202640 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription No No AA 2012/09/17 AUROBINDO PHARMA USA
205136 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Discontinued No No AA 2019/02/22 CHARTWELL RX
213957 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription No No AA 2020/06/23 ZYDUS LIFESCIENCES
200432 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Discontinued No No AA 2022/02/17 INVAGEN PHARMS
203003 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 12.5MG Prescription No No AA 2022/08/11 CHARTWELL RX
活性成分:MECLIZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 治疗等效代码:AA
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
084657 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Discontinued No No AA Approved Prior to Jan 1, 1982 ANI PHARMS
087128 001 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA Approved Prior to Jan 1, 1982 APNAR PHARMA LP
010721 004 NDA ANTIVERT MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription Yes No AA Approved Prior to Jan 1, 1982 CASPER PHARMA LLC
084092 003 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 1989/05/22 INVATECH
040659 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2010/06/04 JUBILANT CADISTA
201451 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No Yes AA 2011/02/23 AMNEAL PHARMS
200294 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2012/04/13 EPIC PHARMA LLC
202640 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2012/09/17 AUROBINDO PHARMA USA
205136 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Discontinued No No AA 2019/02/22 CHARTWELL RX
213957 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2020/06/23 ZYDUS LIFESCIENCES
200432 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Discontinued No No AA 2022/02/17 INVAGEN PHARMS
203003 002 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AA 2022/08/11 CHARTWELL RX
活性成分:MECLIZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 治疗等效代码:AA
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
010721 001 NDA ANTIVERT MECLIZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription Yes Yes AA 1982/01/20 CASPER PHARMA LLC
201451 003 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2011/02/23 AMNEAL PHARMS
202640 003 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2012/09/17 AUROBINDO PHARMA USA
205136 003 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 50MG Discontinued No No AA 2019/02/22 CHARTWELL RX
200432 003 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 50MG Discontinued No No AA 2022/02/17 INVAGEN PHARMS
203003 003 ANDA MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AA 2022/08/11 CHARTWELL RX
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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