药品注册申请号:070581
申请类型:ANDA (仿制药申请)
申请人:STRIDES PHARMA
申请人全名:STRIDES PHARMA GLOBAL PTE 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 METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE No No AB 1985/10/17 1985/10/17 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
2019/07/30 SUPPL-44(补充) Approval Labeling STANDARD
2012/02/21 SUPPL-38(补充) Approval Labeling
2011/02/28 SUPPL-37(补充) Approval Labeling
2010/03/11 SUPPL-35(补充) Approval Labeling
2005/05/05 SUPPL-27(补充) Approval Labeling
2002/05/23 SUPPL-22(补充) Approval Labeling
2002/02/01 SUPPL-20(补充) Approval Labeling
2001/11/02 SUPPL-21(补充) Approval Manufacturing (CMC)
2000/05/26 SUPPL-19(补充) Approval Manufacturing (CMC)
2000/01/27 SUPPL-17(补充) Approval Manufacturing (CMC)
1999/11/24 SUPPL-18(补充) Approval Labeling
1996/01/18 SUPPL-16(补充) Approval Manufacturing (CMC)
1991/07/10 SUPPL-14(补充) Approval Manufacturing (CMC)
1991/03/28 SUPPL-15(补充) Approval Labeling
1988/11/01 SUPPL-12(补充) Approval Labeling
1987/11/23 SUPPL-10(补充) Approval Manufacturing (CMC)
1987/06/23 SUPPL-6(补充) Approval Labeling
1987/06/15 SUPPL-5(补充) Approval Manufacturing (CMC)
1987/06/15 SUPPL-4(补充) Approval Manufacturing (CMC)
1987/06/15 SUPPL-3(补充) Approval Manufacturing (CMC)
1986/11/25 SUPPL-2(补充) Approval Manufacturing (CMC)
1986/11/25 SUPPL-1(补充) Approval Manufacturing (CMC)
1986/09/15 SUPPL-9(补充) Approval Labeling
1985/10/17 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
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:METOCLOPRAMIDE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 10MG BASE 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
017854 001 NDA REGLAN METOCLOPRAMIDE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription Yes Yes AB Approved Prior to Jan 1, 1982 ANI PHARMS
070184 001 ANDA METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 1985/07/29 TEVA
070581 001 ANDA METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 1985/10/17 STRIDES PHARMA
071250 001 ANDA METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 1988/02/03 IMPAX LABS INC
072215 001 ANDA METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 1990/01/30 AIPING PHARM INC
077878 002 ANDA METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2006/08/28 STRIDES PHARMA
078807 002 ANDA METOCLOPRAMIDE HYDROCHLORIDE METOCLOPRAMIDE HYDROCHLORIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2008/06/12 IPCA LABS LTD
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