药品注册申请号:089338
申请类型:ANDA (仿制药申请)
申请人:SUN PHARM INDUSTRIES
申请人全名:SUN PHARMACEUTICAL INDUSTRIES 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 QUINIDINE GLUCONATE QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE;ORAL 324MG No Yes AB 1987/02/11 1987/02/11 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
提交状态日期提交类型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
2010/02/02 Supplemental 36 Approval Labeling
2003/03/31 Supplemental 24 Approval Labeling
2001/07/10 Supplemental 20 Approval Manufacturing (CMC)
2001/06/04 Supplemental 16 Approval Manufacturing (CMC)
2000/07/17 Supplemental 17 Approval Labeling
2000/05/16 Supplemental 19 Approval Manufacturing (CMC)
2000/05/16 Supplemental 18 Approval Manufacturing (CMC)
1999/02/04 Supplemental 15 Approval Labeling
1997/12/05 Supplemental 14 Approval Manufacturing (CMC)
1997/02/24 Supplemental 13 Approval Manufacturing (CMC)
1996/12/06 Supplemental 12 Approval Labeling
1996/04/25 Supplemental 10 Approval Manufacturing (CMC)
1995/07/31 Supplemental 9 Approval Manufacturing (CMC)
1995/06/22 Supplemental 11 Approval Manufacturing (CMC)
1994/01/12 Supplemental 8 Approval Manufacturing (CMC)
1993/06/15 Supplemental 7 Approval Labeling
1991/07/16 Supplemental 6 Approval Manufacturing (CMC)
1990/03/08 Supplemental 5 Approval Labeling
1990/01/12 Supplemental 4 Approval Labeling
1987/07/17 Supplemental 3 Approval Manufacturing (CMC)
1987/07/17 Supplemental 1 Approval Manufacturing (CMC)
1987/02/11 Original(原始申请) 1 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:QUINIDINE GLUCONATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:324MG 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
089338 001 ANDA QUINIDINE GLUCONATE QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE;ORAL 324MG Prescription No Yes AB 1987/02/11 SUN PHARM INDUSTRIES
212589 001 ANDA QUINIDINE GLUCONATE QUINIDINE GLUCONATE TABLET, EXTENDED RELEASE;ORAL 324MG Prescription No No AB 2021/09/17 EYWA
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