药品注册申请号:019771
申请类型:NDA (新药申请)
申请人:PFIZER
申请人全名:PFIZER INC
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 ADVIL COLD AND SINUS IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET;ORAL 200MG;30MG Yes Yes None 1989/09/19 1989/09/19 Over-the-counter
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
2017/03/23 SUPPL 40 Approval Labeling STANDARD
2010/09/02 SUPPL 36 Approval Labeling UNKNOWN
2009/05/19 SUPPL 32 Approval Labeling STANDARD
2008/06/20 SUPPL 31 Approval Labeling STANDARD
2006/04/17 SUPPL 26 Approval Labeling STANDARD
2006/02/23 SUPPL 28 Approval Labeling STANDARD
2003/10/17 SUPPL 22 Approval Labeling STANDARD
2001/08/02 SUPPL 21 Approval Manufacturing (CMC) STANDARD
2001/05/23 SUPPL 20 Approval Labeling STANDARD
2001/05/14 SUPPL 18 Approval Labeling STANDARD
2000/01/18 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1999/06/28 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1997/01/31 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1996/02/01 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1994/08/03 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1994/06/15 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1994/06/13 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1994/04/21 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1994/03/11 SUPPL 8 Approval Labeling STANDARD
1992/05/28 SUPPL 4 Approval Labeling
1991/09/04 SUPPL 7 Approval Labeling
1990/10/17 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1989/09/19 ORIG 1 Approval Type 4 - New Combination STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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