药品注册申请号:011839
申请类型:NDA (新药申请)
申请人:PHARMACIA AND UPJOHN
申请人全名:PHARMACIA AND UPJOHN CO
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 PROVERA MEDROXYPROGESTERONE ACETATE TABLET;ORAL 2.5MG Yes No AB 1959/06/18 Approved Prior to Jan 1, 1982 Prescription
003 PROVERA MEDROXYPROGESTERONE ACETATE TABLET;ORAL 5MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
004 PROVERA MEDROXYPROGESTERONE ACETATE TABLET;ORAL 10MG Yes Yes AB Approved Prior to Jan 1, 1982 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2016/12/01 SUPPL 77 Approval Manufacturing (CMC) STANDARD
2015/05/07 SUPPL 80 Approval Labeling STANDARD
2015/05/07 SUPPL 79 Approval Labeling STANDARD
2007/09/28 SUPPL 71 Approval Labeling STANDARD
1998/08/04 SUPPL 68 Approval Efficacy STANDARD
1998/03/31 SUPPL 67 Approval Labeling STANDARD
1995/11/28 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1993/06/23 SUPPL 63 Approval Manufacturing (CMC) STANDARD
1993/06/23 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1993/04/30 SUPPL 62 Approval Labeling STANDARD
1992/06/19 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1991/12/18 SUPPL 58 Approval Labeling
1991/11/19 SUPPL 60 Approval Labeling
1989/10/06 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1988/06/03 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1987/10/26 SUPPL 50 Approval Labeling
1985/11/01 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1979/07/23 SUPPL 39 Approval Efficacy
1979/06/06 SUPPL 35 Approval Efficacy
1975/10/21 SUPPL 29 Approval REMS STANDARD
1973/10/04 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1959/06/18 ORIG 1 Approval Type 1 - New Molecular Entity 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:MEDROXYPROGESTERONE ACETATE 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
011839 001 NDA PROVERA MEDROXYPROGESTERONE ACETATE TABLET;ORAL 2.5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN
040159 001 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE TABLET;ORAL 2.5MG Prescription No No AB 1996/08/09 BARR
活性成分:MEDROXYPROGESTERONE ACETATE 剂型/给药途径:TABLET;ORAL 规格:5MG 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
011839 003 NDA PROVERA MEDROXYPROGESTERONE ACETATE TABLET;ORAL 5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN
040159 002 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE TABLET;ORAL 5MG Prescription No No AB 1996/08/09 BARR
活性成分:MEDROXYPROGESTERONE ACETATE 剂型/给药途径:TABLET;ORAL 规格:10MG 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
011839 004 NDA PROVERA MEDROXYPROGESTERONE ACETATE TABLET;ORAL 10MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 PHARMACIA AND UPJOHN
040159 003 ANDA MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE TABLET;ORAL 10MG Prescription No No AB 1996/08/09 BARR
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