药品注册申请号:018164
申请类型:NDA (新药申请)
申请人:ATNAHS PHARMA US
申请人全名:ATNAHS PHARMA US 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 ANAPROX NAPROXEN SODIUM TABLET;ORAL EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1980/09/04 Approved Prior to Jan 1, 1982 Discontinued
003 ANAPROX DS NAPROXEN SODIUM TABLET;ORAL EQ 500MG BASE Yes Yes AB 1987/09/30 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
2024/05/13 SUPPL-66(补充) Approval Labeling STANDARD
2021/04/28 SUPPL-65(补充) Approval Labeling STANDARD
2019/07/22 SUPPL-64(补充) Approval Labeling STANDARD
2017/03/10 SUPPL-63(补充) Approval Labeling STANDARD
2016/05/09 SUPPL-62(补充) Approval Labeling STANDARD
2013/03/22 SUPPL-61(补充) Approval Labeling STANDARD
2008/07/25 SUPPL-60(补充) Approval Labeling STANDARD
2007/09/20 SUPPL-58(补充) Approval Labeling STANDARD
2007/04/19 SUPPL-57(补充) Approval Labeling STANDARD
2006/03/10 SUPPL-55(补充) Approval Labeling STANDARD
2006/01/24 SUPPL-56(补充) Approval Labeling STANDARD
2004/11/10 SUPPL-51(补充) Approval Labeling STANDARD
2004/11/10 SUPPL-50(补充) Approval Labeling STANDARD
2003/04/14 SUPPL-49(补充) Approval Labeling STANDARD
2002/02/22 SUPPL-54(补充) Approval Manufacturing (CMC) STANDARD
2001/11/09 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
2000/12/08 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1995/02/08 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
1994/09/06 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1993/12/15 SUPPL-46(补充) Approval Labeling STANDARD
1992/08/12 SUPPL-45(补充) Approval Manufacturing (CMC) STANDARD
1992/05/08 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1990/10/02 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
1987/09/30 SUPPL-36(补充) Approval Efficacy
1987/09/30 SUPPL-35(补充) Approval Efficacy
1987/09/30 SUPPL-34(补充) Approval Labeling
1987/09/30 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1987/09/30 SUPPL-15(补充) Approval Labeling
1986/08/29 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1986/06/10 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1985/09/24 SUPPL-31(补充) Approval Labeling
1985/05/03 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1985/04/29 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1985/04/23 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1983/09/09 SUPPL-21(补充) Approval Labeling
1983/09/09 SUPPL-12(补充) Approval Labeling
1983/02/22 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1982/12/07 SUPPL-17(补充) Approval Labeling
1982/12/07 SUPPL-16(补充) Approval Labeling
1982/10/18 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1982/05/10 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1982/04/22 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1982/04/22 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1982/04/22 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1982/01/07 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1982/01/07 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1981/10/13 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1981/10/13 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1981/04/13 SUPPL-1(补充) Approval Labeling
1980/09/04 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer STANDARD
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:NAPROXEN SODIUM 剂型/给药途径:TABLET;ORAL 规格:EQ 500MG 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
018164 003 NDA ANAPROX DS NAPROXEN SODIUM TABLET;ORAL EQ 500MG BASE Prescription Yes Yes AB 1987/09/30 ATNAHS PHARMA US
078432 002 ANDA NAPROXEN SODIUM NAPROXEN SODIUM TABLET;ORAL EQ 500MG BASE Prescription No No AB 2007/04/25 AMNEAL PHARMS NY
078314 002 ANDA NAPROXEN SODIUM NAPROXEN SODIUM TABLET;ORAL EQ 500MG BASE Prescription No No AB 2007/04/27 GLENMARK PHARMS LTD
078486 002 ANDA NAPROXEN SODIUM NAPROXEN SODIUM TABLET;ORAL EQ 500MG BASE Prescription No No AB 2007/07/26 DR REDDYS LABS LTD
200629 002 ANDA NAPROXEN SODIUM NAPROXEN SODIUM TABLET;ORAL EQ 500MG BASE Prescription No No AB 2011/10/31 AUROBINDO PHARMA LTD
212199 002 ANDA NAPROXEN SODIUM NAPROXEN SODIUM TABLET;ORAL EQ 500MG BASE Prescription No No AB 2019/10/30 SCIEGEN PHARMS INC
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