药品注册申请号:061926
申请类型:ANDA (仿制药申请)
申请人:TEVA
申请人全名:TEVA PHARMACEUTICALS USA 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 AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 250MG No No AB 1976/02/09 Approved Prior to Jan 1, 1982 Prescription
003 AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 500MG No Yes AB Approved Prior to Jan 1, 1982 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
2024/01/03 SUPPL-132(补充) Approval Labeling STANDARD
2019/12/04 SUPPL-131(补充) Approval Labeling STANDARD
2017/05/18 SUPPL-128(补充) Approval Labeling STANDARD
2017/05/18 SUPPL-127(补充) Approval Labeling STANDARD
2015/09/10 SUPPL-121(补充) Approval Labeling
2009/02/02 SUPPL-117(补充) Approval Labeling
2008/07/17 SUPPL-116(补充) Approval Labeling
2007/05/31 SUPPL-113(补充) Approval Labeling
2003/07/30 SUPPL-110(补充) Approval Labeling
2002/11/20 SUPPL-106(补充) Approval Manufacturing (CMC)
2002/11/20 SUPPL-105(补充) Approval Manufacturing (CMC)
2002/04/19 SUPPL-101(补充) Approval Manufacturing (CMC)
2002/04/19 SUPPL-100(补充) Approval Manufacturing (CMC)
2002/03/14 SUPPL-102(补充) Approval Manufacturing (CMC)
2001/09/17 SUPPL-98(补充) Approval Manufacturing (CMC)
2001/07/24 SUPPL-96(补充) Approval Manufacturing (CMC)
2001/07/13 SUPPL-99(补充) Approval Labeling
2001/05/15 SUPPL-95(补充) Approval Manufacturing (CMC)
2001/03/23 SUPPL-97(补充) Approval Labeling
2001/01/04 SUPPL-94(补充) Approval Manufacturing (CMC)
2000/07/07 SUPPL-93(补充) Approval Manufacturing (CMC)
1999/04/06 SUPPL-91(补充) Approval Labeling
1997/12/10 SUPPL-90(补充) Approval Manufacturing (CMC)
1997/06/09 SUPPL-89(补充) Approval Manufacturing (CMC)
1996/08/27 SUPPL-88(补充) Approval Manufacturing (CMC)
1996/05/08 SUPPL-87(补充) Approval Manufacturing (CMC)
1995/06/30 SUPPL-86(补充) Approval Manufacturing (CMC)
1993/11/26 SUPPL-85(补充) Approval Labeling
1993/09/02 SUPPL-82(补充) Approval Manufacturing (CMC)
1993/06/28 SUPPL-83(补充) Approval Labeling
1992/08/14 SUPPL-81(补充) Approval Labeling
1989/03/28 SUPPL-79(补充) Approval Manufacturing (CMC)
1976/02/09 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:AMOXICILLIN 剂型/给药途径:CAPSULE;ORAL 规格:250MG 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
061926 001 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 250MG Prescription No No AB Approved Prior to Jan 1, 1982 TEVA
062058 001 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 250MG Prescription No No AB Approved Prior to Jan 1, 1982 CHARTWELL
062216 001 ANDA AMOXIL AMOXICILLIN CAPSULE;ORAL 250MG Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
064076 001 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 250MG Prescription No No AB 1994/09/30 SANDOZ
065271 001 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 250MG Prescription No No AB 2005/11/09 AUROBINDO
065291 001 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 250MG Prescription No No AB 2007/02/05 HIKMA PHARMS
207471 001 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 250MG Prescription No No AB 2022/06/24 MICRO LABS
活性成分:AMOXICILLIN 剂型/给药途径:CAPSULE;ORAL 规格:500MG 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
061926 003 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 500MG Prescription No Yes AB Approved Prior to Jan 1, 1982 TEVA
062058 002 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 500MG Prescription No No AB Approved Prior to Jan 1, 1982 CHARTWELL
062216 004 ANDA AMOXIL AMOXICILLIN CAPSULE;ORAL 500MG Prescription No No AB Approved Prior to Jan 1, 1982 US ANTIBIOTICS
064076 002 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 500MG Prescription No No AB 1994/09/30 SANDOZ
065271 002 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 500MG Prescription No No AB 2005/11/09 AUROBINDO
065291 002 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 500MG Prescription No No AB 2007/02/05 HIKMA PHARMS
207471 002 ANDA AMOXICILLIN AMOXICILLIN CAPSULE;ORAL 500MG Prescription No No AB 2022/06/24 MICRO LABS
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药品NDC数据与药品包装、标签说明书
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