药品注册申请号:073457
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN PHARMACEUTICALS 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 ATENOLOL ATENOLOL TABLET;ORAL 100MG No No AB 1992/01/24 1992/01/24 Prescription
002 ATENOLOL ATENOLOL TABLET;ORAL 25MG No No AB 1999/04/26 Prescription
003 ATENOLOL ATENOLOL TABLET;ORAL 50MG No No AB 1992/01/24 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
2015/07/01 SUPPL-35(补充) Approval Labeling STANDARD
2005/12/12 SUPPL-26(补充) Approval Labeling
2004/02/06 SUPPL-24(补充) Approval Labeling
2003/10/28 SUPPL-23(补充) Approval Labeling
2003/01/03 SUPPL-21(补充) Approval Manufacturing (CMC)
2001/02/15 SUPPL-20(补充) Approval Manufacturing (CMC)
2000/08/10 SUPPL-19(补充) Approval Labeling
2000/06/07 SUPPL-18(补充) Approval Labeling
1999/04/26 SUPPL-15(补充) Approval Labeling
1999/04/26 SUPPL-14(补充) Approval Manufacturing (CMC)
1999/04/26 SUPPL-13(补充) Approval Manufacturing (CMC)
1999/04/26 SUPPL-12(补充) Approval Manufacturing (CMC)
1999/04/05 SUPPL-17(补充) Approval Manufacturing (CMC)
1999/02/25 SUPPL-16(补充) Approval Labeling
1998/08/14 SUPPL-11(补充) Approval Manufacturing (CMC)
1998/02/05 SUPPL-10(补充) Approval Manufacturing (CMC)
1997/02/13 SUPPL-9(补充) Approval Labeling
1996/10/30 SUPPL-8(补充) Approval Manufacturing (CMC)
1994/08/29 SUPPL-7(补充) Approval Labeling
1993/08/31 SUPPL-6(补充) Approval Labeling
1993/02/08 SUPPL-4(补充) Approval Labeling
1992/12/21 SUPPL-3(补充) Approval Labeling
1992/10/05 SUPPL-2(补充) Approval Labeling
1992/05/20 SUPPL-1(补充) Approval Labeling
1992/01/24 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:ATENOLOL 剂型/给药途径:TABLET;ORAL 规格:100MG 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
018240 002 NDA TENORMIN ATENOLOL TABLET;ORAL 100MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 TWI PHARMS
072304 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 1988/07/15 TWI PHARMS
073026 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 1991/09/17 HLTHCARE
073457 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 1992/01/24 MYLAN
074056 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 1995/01/18 TEVA
076900 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 2005/01/28 ZYDUS PHARMS USA
077443 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 2006/09/13 UNIQUE
077877 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 2006/12/27 IPCA LABS LTD
078512 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 2007/10/31 AUROBINDO PHARMA
213136 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 100MG Prescription No No AB 2019/11/21 UNICHEM
活性成分:ATENOLOL 剂型/给药途径:TABLET;ORAL 规格:25MG 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
018240 004 NDA TENORMIN ATENOLOL TABLET;ORAL 25MG Prescription Yes No AB 1990/04/09 TWI PHARMS
073026 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 1992/05/01 HLTHCARE
072304 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 1992/07/31 TWI PHARMS
073457 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 1999/04/26 MYLAN
074056 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 2004/07/19 TEVA
076900 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 2005/01/28 ZYDUS PHARMS USA
077443 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 2006/09/13 UNIQUE
077877 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 2006/12/27 IPCA LABS LTD
078512 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 2007/10/31 AUROBINDO PHARMA
213136 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 25MG Prescription No No AB 2019/11/21 UNICHEM
活性成分:ATENOLOL 剂型/给药途径:TABLET;ORAL 规格:50MG 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
018240 001 NDA TENORMIN ATENOLOL TABLET;ORAL 50MG Prescription Yes No AB Approved Prior to Jan 1, 1982 TWI PHARMS
072304 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 1988/07/18 TWI PHARMS
073026 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 1991/09/17 HLTHCARE
073457 003 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 1992/01/24 MYLAN
074056 001 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 1995/01/18 TEVA
076900 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 2005/01/28 ZYDUS PHARMS USA
077443 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 2006/09/13 UNIQUE
077877 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 2006/12/27 IPCA LABS LTD
078512 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 2007/10/31 AUROBINDO PHARMA
213136 002 ANDA ATENOLOL ATENOLOL TABLET;ORAL 50MG Prescription No No AB 2019/11/21 UNICHEM
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