药品注册申请号：017534
申请类型：NDA (新药申请)
申请人：ALLERGAN
申请人全名：ALLERGAN SALES 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
003 FIORINAL ASPIRIN; BUTALBITAL; CAFFEINE TABLET;ORAL 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1976/05/04 1986/04/16 Discontinued
005 FIORINAL ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No AA 1986/04/16 Discontinued
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1976/05/04 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2021/04/28 SUPPL-74（补充） Approval Labeling-Package Insert STANDARD
2014/10/16 SUPPL-73（补充） Approval Manufacturing (CMC) STANDARD
2014/07/21 SUPPL-72（补充） Approval Manufacturing (CMC) STANDARD
2013/06/03 SUPPL-71（补充） Approval Manufacturing (CMC) STANDARD
2002/04/26 SUPPL-56（补充） Approval Manufacturing (CMC)-Control STANDARD
2001/06/28 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
2001/05/30 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
1999/11/10 SUPPL-51（补充） Approval Manufacturing (CMC) STANDARD
1999/04/22 SUPPL-50（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1999/03/01 SUPPL-49（补充） Approval Manufacturing (CMC)-Control STANDARD
1997/02/27 SUPPL-40（补充） Approval Labeling
1996/01/18 SUPPL-45（补充） Approval Labeling STANDARD
1995/11/24 SUPPL-48（补充） Approval Manufacturing (CMC) STANDARD
1995/10/20 SUPPL-46（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/04/05 SUPPL-43（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/05/18 SUPPL-29（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1994/04/05 SUPPL-44（补充） Approval Manufacturing (CMC) STANDARD
1993/03/19 SUPPL-42（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1993/03/19 SUPPL-41（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1992/08/14 SUPPL-39（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/07/27 SUPPL-38（补充） Approval Labeling
1992/07/27 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1992/07/27 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/07/22 SUPPL-37（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/07/22 SUPPL-33（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/07/22 SUPPL-32（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1989/04/07 SUPPL-31（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/11/17 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/03/31 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
1986/04/16 SUPPL-22（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1985/02/15 SUPPL-25（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/02/15 SUPPL-24（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1984/12/11 SUPPL-23（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1981/08/10 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1981/08/10 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1981/01/29 SUPPL-19（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1980/12/18 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1979/12/21 SUPPL-15（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1979/09/14 SUPPL-14（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1979/05/31 SUPPL-13（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1979/05/31 SUPPL-12（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1979/04/11 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1978/12/15 SUPPL-10（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1978/10/13 SUPPL-8（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1978/10/12 SUPPL-9（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1978/10/06 SUPPL-7（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1978/03/21 SUPPL-5（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1978/03/21 SUPPL-4（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1977/12/14 SUPPL-6（补充） Approval Manufacturing (CMC)-Expiration Date STANDARD
1977/08/31 SUPPL-3（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1976/07/30 SUPPL-1（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1976/06/30 SUPPL-2（补充） Approval Manufacturing (CMC)-Packaging 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
无
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
无
与本品治疗等效的药品
>>>活性成分:ASPIRIN; BUTALBITAL; CAFFEINE; 剂型/给药途径:CAPSULE;ORAL; 规格:325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AA<<<
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
017534 005 NDA FIORINAL ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE;ORAL 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued Yes No AA 1986/04/16 ALLERGAN
更多信息
药品NDC数据与药品包装、标签说明书
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