药品注册申请号：018343
申请类型：NDA (新药申请)
申请人：AARXION ANDA HLDING
申请人全名：AARXION ANDA HOLDING 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001 CAPOTEN CAPTOPRIL TABLET;ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1981/04/06 Approved Prior to Jan 1, 1982 Discontinued
002 CAPOTEN CAPTOPRIL TABLET;ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 CAPOTEN CAPTOPRIL TABLET;ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 CAPOTEN CAPTOPRIL TABLET;ORAL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1995/06/13 Discontinued
005 CAPOTEN CAPTOPRIL TABLET;ORAL 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1985/01/17 Discontinued
006 CAPOTEN CAPTOPRIL TABLET;ORAL 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1986/09/17 Discontinued
007 CAPOTEN CAPTOPRIL TABLET;ORAL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1995/06/13 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1981/04/06 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2017/08/01 SUPPL-87（补充） Approval Labeling-Package Insert STANDARD
2015/06/19 SUPPL-86（补充） Approval Labeling-Package Insert STANDARD
2014/12/24 SUPPL-85（补充） Approval Labeling-Package Insert STANDARD
2012/08/27 SUPPL-84（补充） Approval Labeling-Package Insert UNKNOWN
2011/12/14 SUPPL-83（补充） Approval Labeling-Package Insert UNKNOWN
2011/05/19 SUPPL-82（补充） Approval Labeling-Package Insert UNKNOWN
2008/09/25 SUPPL-81（补充） Approval Labeling STANDARD
2004/05/07 SUPPL-75（补充） Approval Labeling STANDARD
1999/04/20 SUPPL-73（补充） Approval Labeling STANDARD
1998/01/09 SUPPL-72（补充） Approval Manufacturing (CMC)-Control PRIORITY
1997/08/21 SUPPL-71（补充） Approval Manufacturing (CMC)-Control PRIORITY
1996/07/31 SUPPL-68（补充） Approval Labeling STANDARD
1996/06/25 SUPPL-70（补充） Approval Manufacturing (CMC) PRIORITY
1996/03/01 SUPPL-69（补充） Approval Manufacturing (CMC)-Control PRIORITY
1995/06/19 SUPPL-57（补充） Approval Manufacturing (CMC)-Control PRIORITY
1995/06/13 SUPPL-66（补充） Approval Manufacturing (CMC)-Formulation PRIORITY
1995/03/06 SUPPL-67（补充） Approval Manufacturing (CMC)-Control PRIORITY
1994/03/31 SUPPL-63（补充） Approval Labeling STANDARD
1994/01/28 SUPPL-64（补充） Approval Efficacy-New Indication PRIORITY
1993/11/04 SUPPL-65（补充） Approval Labeling STANDARD
1993/09/23 SUPPL-48（补充） Approval Efficacy-New Indication
1993/05/12 SUPPL-62（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1992/12/21 SUPPL-59（补充） Approval Manufacturing (CMC)-Control PRIORITY
1992/09/03 SUPPL-60（补充） Approval Labeling
1992/06/25 SUPPL-61（补充） Approval Labeling
1992/05/07 SUPPL-56（补充） Approval Manufacturing (CMC)-Formulation PRIORITY
1992/01/14 SUPPL-58（补充） Approval Manufacturing (CMC)-Control PRIORITY
1991/10/07 SUPPL-55（补充） Approval Manufacturing (CMC) PRIORITY
1991/04/12 SUPPL-53（补充） Approval Manufacturing (CMC) PRIORITY
1991/03/21 SUPPL-51（补充） Approval Labeling
1991/01/31 SUPPL-54（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1990/11/05 SUPPL-52（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1990/09/27 SUPPL-50（补充） Approval Labeling
1990/05/10 SUPPL-49（补充） Approval Manufacturing (CMC) PRIORITY
1990/03/23 SUPPL-32（补充） Approval Manufacturing (CMC)-Control PRIORITY
1989/10/19 SUPPL-46（补充） Approval Labeling
1989/05/03 SUPPL-47（补充） Approval Labeling
1988/05/13 SUPPL-45（补充） Approval Manufacturing (CMC)-Control PRIORITY
1988/05/13 SUPPL-40（补充） Approval Efficacy-New Indication
1988/02/19 SUPPL-44（补充） Approval Labeling
1987/06/26 SUPPL-41（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1987/04/02 SUPPL-36（补充） Approval Manufacturing (CMC) PRIORITY
1987/02/13 SUPPL-37（补充） Approval Manufacturing (CMC)-Control PRIORITY
1987/01/21 SUPPL-38（补充） Approval Manufacturing (CMC)-Control PRIORITY
1987/01/06 SUPPL-39（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1986/09/17 SUPPL-30（补充） Approval Manufacturing (CMC)-Control PRIORITY
1986/08/14 SUPPL-35（补充） Approval Manufacturing (CMC) PRIORITY
1986/07/24 SUPPL-33（补充） Approval Manufacturing (CMC)-Control PRIORITY
1986/05/27 SUPPL-29（补充） Approval Manufacturing (CMC)-Control PRIORITY
1986/03/04 SUPPL-31（补充） Approval Manufacturing (CMC)-Control PRIORITY
1986/02/27 SUPPL-28（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1986/01/17 SUPPL-27（补充） Approval Labeling
1985/12/18 SUPPL-26（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1985/07/10 SUPPL-9（补充） Approval Labeling
1985/06/12 SUPPL-24（补充） Approval Manufacturing (CMC) PRIORITY
1985/04/16 SUPPL-25（补充） Approval Manufacturing (CMC)-Control PRIORITY
1985/04/16 SUPPL-23（补充） Approval Manufacturing (CMC)-Control PRIORITY
1985/01/17 SUPPL-18（补充） Approval Efficacy
1984/11/19 SUPPL-22（补充） Approval Manufacturing (CMC)-Control PRIORITY
1984/10/12 SUPPL-21（补充） Approval Labeling
1984/09/18 SUPPL-17（补充） Approval Manufacturing (CMC)-Control PRIORITY
1984/08/28 SUPPL-14（补充） Approval Efficacy
1984/07/12 SUPPL-20（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1984/06/08 SUPPL-16（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1984/06/08 SUPPL-15（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1984/02/07 SUPPL-12（补充） Approval Manufacturing (CMC)-Expiration Date PRIORITY
1984/02/07 SUPPL-8（补充） Approval Manufacturing (CMC) PRIORITY
1983/10/14 SUPPL-13（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
1983/10/14 SUPPL-11（补充） Approval Manufacturing (CMC)-Formulation PRIORITY
1983/05/18 SUPPL-10（补充） Approval Manufacturing (CMC)-Control PRIORITY
1982/10/25 SUPPL-5（补充） Approval Efficacy
1982/10/07 SUPPL-2（补充） Approval Manufacturing (CMC)-Control PRIORITY
1982/03/09 SUPPL-7（补充） Approval Manufacturing (CMC)-Control PRIORITY
1982/02/25 SUPPL-6（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/11/30 SUPPL-4（补充） Approval Manufacturing (CMC)-Formulation PRIORITY
1981/10/27 SUPPL-3（补充） Approval Manufacturing (CMC)-Control PRIORITY
1981/06/12 SUPPL-1（补充） Approval Manufacturing (CMC)-Packaging PRIORITY
与本品相关的专利信息（来自FDA橙皮书Orange Book）
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001 5238924 2010/08/24 U-92 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5238924 2010/08/24 U-92 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5238924 2010/08/24 U-92 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5238924 2010/08/24 U-92 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5238924 2010/08/24 U-92 PDF格式**本条是由Drugfuture回溯的历史信息**
006 5238924 2010/08/24 U-92 PDF格式**本条是由Drugfuture回溯的历史信息**
007 5238924 2010/08/24 U-92 PDF格式**本条是由Drugfuture回溯的历史信息**
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
本品无治疗等效药品
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