药品注册申请号:012541
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
002 DEPO-PROVERA MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1960/09/23 Approved Prior to Jan 1, 1982 Discontinued
003 DEPO-PROVERA MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 400MG/ML Yes Yes None 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
2017/04/03 SUPPL 86 Approval Labeling STANDARD
2017/03/15 SUPPL 88 Approval Labeling STANDARD
2016/12/16 SUPPL 85 Approval Labeling STANDARD
2016/06/10 SUPPL 84 Approval Labeling STANDARD
2015/06/11 SUPPL 83 Approval Labeling STANDARD
2014/06/09 SUPPL 82 Approval Manufacturing (CMC) STANDARD
2012/11/20 SUPPL 78 Approval Manufacturing (CMC) STANDARD
2000/04/03 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1997/11/28 SUPPL 67 Approval Labeling STANDARD
1995/11/28 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1995/09/07 SUPPL 57 Approval Labeling
1995/04/18 SUPPL 65 Approval Manufacturing (CMC) STANDARD
1995/04/12 SUPPL 64 Approval Manufacturing (CMC) STANDARD
1994/07/27 SUPPL 63 Approval Manufacturing (CMC) STANDARD
1994/06/16 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1994/02/18 SUPPL 60 Approval Labeling STANDARD
1994/02/17 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1993/06/23 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1990/02/20 SUPPL 56 Approval Labeling
1980/05/20 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1979/07/13 SUPPL 48 Approval Labeling
1979/01/19 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1978/12/04 SUPPL 42 Approval Labeling
1976/11/01 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1976/11/01 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1976/11/01 SUPPL 38 Approval Labeling
1976/01/16 SUPPL 36 Approval Labeling
1960/09/23 ORIG 1 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
本品无治疗等效药品
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