药品注册申请号:089536
申请类型:ANDA (仿制药申请)
申请人:WATSON LABS
申请人全名:WATSON LABORATORIES 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 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG No No None 1988/02/16 1988/02/16 Discontinued
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
2015/11/03 SUPPL 25 Approval Labeling
2003/09/29 SUPPL 24 Approval Labeling
2002/09/05 SUPPL 22 Approval Manufacturing (CMC)
2002/07/24 SUPPL 23 Approval Manufacturing (CMC)
2002/07/24 SUPPL 20 Approval Manufacturing (CMC)
2002/05/03 SUPPL 21 Approval Manufacturing (CMC)
2002/02/08 SUPPL 18 Approval Manufacturing (CMC)
2002/02/08 SUPPL 17 Approval Manufacturing (CMC)
2001/11/02 SUPPL 15 Approval Manufacturing (CMC)
2001/09/24 SUPPL 16 Approval Manufacturing (CMC)
2000/12/18 SUPPL 14 Approval Manufacturing (CMC)
2000/12/18 SUPPL 13 Approval Manufacturing (CMC)
2000/12/18 SUPPL 12 Approval Manufacturing (CMC)
2000/12/18 SUPPL 11 Approval Manufacturing (CMC)
2000/08/08 SUPPL 10 Approval Manufacturing (CMC)
1997/06/02 SUPPL 5 Approval Manufacturing (CMC)
1997/02/04 SUPPL 9 Approval Manufacturing (CMC)
1994/08/16 SUPPL 8 Approval Labeling
1992/05/08 SUPPL 7 Approval Labeling
1991/08/16 SUPPL 6 Approval Labeling
1988/02/16 ORIG 1 Approval
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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