药品注册申请号:020527
申请类型:NDA (新药申请)
申请人:WYETH PHARMS
申请人全名:WYETH PHARMACEUTICALS 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 PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE TABLET;ORAL-28 0.625MG;2.5MG Yes Yes None 1995/11/17 1995/11/17 Prescription
002 PREMPHASE 14/14 ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE TABLET;ORAL-28 0.625MG,0.625MG;N/A,5MG Yes Yes None 1995/11/17 Prescription
003 PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE TABLET;ORAL-28 0.625MG;5MG Yes Yes None 1998/01/09 Prescription
004 PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE TABLET;ORAL-28 0.45MG;1.5MG Yes Yes None 2003/03/12 Prescription
005 PREMPRO ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE TABLET;ORAL-28 0.3MG;1.5MG Yes Yes None 2003/06/04 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
2017/11/01 SUPPL 65 Approval Labeling STANDARD
2016/05/04 SUPPL 63 Approval Manufacturing (CMC) STANDARD
2016/02/25 SUPPL 61 Approval Manufacturing (CMC) STANDARD
2015/08/31 SUPPL 62 Approval Labeling STANDARD
2014/07/01 SUPPL 59 Approval Manufacturing (CMC) STANDARD
2012/02/02 SUPPL 56 Approval Labeling UNKNOWN
2012/02/02 SUPPL 54 Approval Labeling UNKNOWN
2012/02/02 SUPPL 52 Approval Manufacturing (CMC) STANDARD
2012/02/02 SUPPL 51 Approval Labeling UNKNOWN
2009/12/30 SUPPL 45 Approval Labeling STANDARD
2009/05/18 SUPPL 46 Approval Manufacturing (CMC) STANDARD
2008/03/03 SUPPL 43 Approval Labeling STANDARD
2006/07/27 SUPPL 37 Approval Labeling STANDARD
2005/06/30 SUPPL 36 Approval Labeling STANDARD
2004/04/20 SUPPL 35 Approval Labeling STANDARD
2004/04/20 SUPPL 34 Approval Labeling STANDARD
2003/06/04 SUPPL 31 Approval Labeling STANDARD
2003/06/04 SUPPL 26 Approval Labeling STANDARD
2003/06/04 SUPPL 24 Approval Efficacy STANDARD
2003/03/12 SUPPL 17 Approval Efficacy STANDARD
2003/01/07 SUPPL 30 Approval Labeling STANDARD
2002/11/27 SUPPL 29 Approval Labeling STANDARD
2002/07/10 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2002/02/11 SUPPL 18 Approval Labeling STANDARD
2001/12/03 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2000/01/06 SUPPL 15 Approval Labeling STANDARD
1999/03/18 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1998/05/12 SUPPL 13 Approval Labeling STANDARD
1998/03/10 SUPPL 9 Approval Labeling STANDARD
1998/01/09 SUPPL 6 Approval Efficacy STANDARD
1997/08/08 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1997/07/31 SUPPL 4 Approval Labeling STANDARD
1997/06/30 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1997/01/24 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1996/12/18 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1996/06/28 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1996/06/27 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1995/11/17 ORIG 1 Approval Type 3 - New Dosage Form 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
001 5547948 2015/01/17 PDF格式**本条是由Drugfuture回溯的历史信息**
002 5547948 2015/01/17 PDF格式**本条是由Drugfuture回溯的历史信息**
003 5547948 2015/01/17 PDF格式**本条是由Drugfuture回溯的历史信息**
004 5547948 2015/01/17 PDF格式**本条是由Drugfuture回溯的历史信息**
005 5547948 2015/01/17 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
与本品治疗等效的药品
本品无治疗等效药品
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