药品注册申请号：016418
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 INDERAL PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1967/11/13 Approved Prior to Jan 1, 1982 Discontinued
002 INDERAL PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 INDERAL PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 INDERAL PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
009 INDERAL PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/10/18 Discontinued
010 INDERAL PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/10/18 Discontinued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
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2011/03/17 SUPPL-80（补充） Approval Labeling UNKNOWN
2008/05/06 SUPPL-79（补充） Approval Labeling STANDARD
2007/09/06 SUPPL-78（补充） Approval Labeling STANDARD
2007/02/21 SUPPL-77（补充） Approval Labeling STANDARD
2006/12/29 SUPPL-76（补充） Approval Labeling STANDARD
2004/08/18 SUPPL-73（补充） Approval Labeling STANDARD
2002/02/06 SUPPL-72（补充） Approval Labeling STANDARD
1999/08/22 SUPPL-71（补充） Approval Labeling STANDARD
1997/11/07 SUPPL-70（补充） Approval Labeling STANDARD
1990/02/15 SUPPL-69（补充） Approval Labeling
1989/03/30 SUPPL-68（补充） Approval Manufacturing (CMC) PRIORITY
1988/05/25 SUPPL-67（补充） Approval Manufacturing (CMC) PRIORITY
1987/01/20 SUPPL-66（补充） Approval Manufacturing (CMC) PRIORITY
1986/10/31 SUPPL-51（补充） Approval Efficacy
1986/10/31 SUPPL-44（补充） Approval Efficacy
1986/10/31 SUPPL-35（补充） Approval Efficacy
1985/10/09 SUPPL-64（补充） Approval Manufacturing (CMC) PRIORITY
1985/06/18 SUPPL-55（补充） Approval Manufacturing (CMC) PRIORITY
1985/02/28 SUPPL-63（补充） Approval Manufacturing (CMC) PRIORITY
1985/02/25 SUPPL-61（补充） Approval Manufacturing (CMC) PRIORITY
1985/02/22 SUPPL-57（补充） Approval Manufacturing (CMC) PRIORITY
1984/12/20 SUPPL-62（补充） Approval Manufacturing (CMC) PRIORITY
1984/05/21 SUPPL-58（补充） Approval Manufacturing (CMC) PRIORITY
1984/01/12 SUPPL-56（补充） Approval Manufacturing (CMC) PRIORITY
1983/09/30 SUPPL-47（补充） Approval Efficacy
1983/03/21 SUPPL-41（补充） Approval Manufacturing (CMC) PRIORITY
1983/01/21 SUPPL-54（补充） Approval Labeling
1983/01/07 SUPPL-53（补充） Approval Manufacturing (CMC) PRIORITY
1982/11/12 SUPPL-52（补充） Approval Manufacturing (CMC) PRIORITY
1982/10/18 SUPPL-49（补充） Approval Labeling
1982/10/18 SUPPL-48（补充） Approval Efficacy
1982/02/08 SUPPL-46（补充） Approval Manufacturing (CMC) PRIORITY
1982/01/26 SUPPL-43（补充） Approval Labeling
1981/10/15 SUPPL-45（补充） Approval Manufacturing (CMC) PRIORITY
1980/09/19 SUPPL-39（补充） Approval Manufacturing (CMC) PRIORITY
1980/09/16 SUPPL-38（补充） Approval Manufacturing (CMC) PRIORITY
1980/03/24 SUPPL-37（补充） Approval Manufacturing (CMC) PRIORITY
1980/03/24 SUPPL-36（补充） Approval Manufacturing (CMC) PRIORITY
1979/05/03 SUPPL-32（补充） Approval Manufacturing (CMC) PRIORITY
1979/03/21 SUPPL-33（补充） Approval Manufacturing (CMC) PRIORITY
1979/03/07 SUPPL-34（补充） Approval Manufacturing (CMC) PRIORITY
1979/03/07 SUPPL-24（补充） Approval Labeling
1979/02/12 SUPPL-31（补充） Approval Manufacturing (CMC) PRIORITY
1979/01/17 SUPPL-25（补充） Approval Efficacy
1978/12/12 SUPPL-29（补充） Approval Labeling
1978/08/21 SUPPL-20（补充） Approval Labeling
1978/08/03 SUPPL-30（补充） Approval Manufacturing (CMC) PRIORITY
1978/04/24 SUPPL-27（补充） Approval Manufacturing (CMC) PRIORITY
1978/04/24 SUPPL-26（补充） Approval Manufacturing (CMC) PRIORITY
1978/02/14 SUPPL-28（补充） Approval Manufacturing (CMC) PRIORITY
1977/12/08 SUPPL-23（补充） Approval Manufacturing (CMC) PRIORITY
1977/11/03 SUPPL-22（补充） Approval Manufacturing (CMC) PRIORITY
1976/09/21 SUPPL-21（补充） Approval Manufacturing (CMC) PRIORITY
1975/02/18 SUPPL-16（补充） Approval Labeling
1967/11/13 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity PRIORITY
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
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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